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Warning Letters PDF .pdf



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Title: https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/
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Related Articles: 2
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.

Snapshot: 2015 Medical Device
Quality-Related Warning Letters
Health News Daily Jan. 22, 2016

Printed by Mr. Norm Rabin, Maetrics LLC

Snapshot: 2015 Medical Device
Quality-Related Warning Letters
“The Gray Sheet” Jan. 21, 2016

Compilation: 2015 Medical Device
Warning Letters
View Full Issue
Regulatory Correspondence / Word Count: 2919 / Article # 01160118001 /
Posted: January 21 2016 11:00 AM

Executive Summary
Complete list of all 91 FDA device-related warning letters released by the
agency last year. The upshot: 73 domestic and 18 foreign manufacturers were
sent letters.

For a quick breakdown of 2015 warning letter data, see "Snapshot: 2015
Medical Device Quality-Related Warning Letters" — "The Gray Sheet," Jan.
21, 2016.
The following is a list of warning letters to medical device manufacturers
released by FDA during calendar year 2015; it is listed alphabetically by
company.
Each listing includes the recipient’s name, the types of products manufactured
by the firm or the type of service provided, close-out letter determination, and
the FDA district office that sent the letter. Warning letters sent to foreign
manufacturers are typically issued by FDA’s Center for Devices and
Radiological Health (CDRH).
The violations summary describes problem areas addressed in the letter,
including specific Quality System Regulation
(21 CFR, Part 820) sections
cited.
The violations summary describes the quality problem areas addressed in the
letter, including the specific Quality System Regulation section cited. Because
of their close relationship to quality operations, citations concerning the Medical
Device Reporting
regulation (21 CFR, Part 803) and the Corrections and
Removals
regulation (21 CFR, Part 806) are included.
Letters with premarket approval (PMA) violations are also noted.

Topics Covered in
this Article
Click a keyword for related
articles.
General Topics
quality assurance
compliance
warning letter
SilverSheet
Subjects
Regulatory
Enforcement
Post-Market Regulation
Manufacturing
Pre-Market Regulation
Industries
Medical Devices
Companies
Cooper Cos. Inc.
CooperSurgical Inc.
EMcision Ltd.
Hoya Corp.
Insulet Corp.
Acelity LP Inc.
LifeCell Corp.
Merge Healthcare Inc.
Natus Medical Inc.
Nephros Inc.
OxySure Systems Inc.
Smith & Nephew PLC
Smith & Nephew Inc.
Stanmore Implants Worldwide Ltd.
Young Innovations Inc.

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Page 2 of 13

Recipient

Violations

9mm Special Effects

CAPA [100] • Design controls [30a] •
Process validation [75a] • Production
and process controls [70a] •
Management responsibility [20e] •
Purchasing controls [50] • Handling
[140] • Medical Device Reporting
[803.17] • PMA

Product(s): Contact Lenses
Close-out letter? Not yet
Issuer: San Francisco District Office

A1 Engineering
Product(s): Neurotris
Close-out letter? Not yet
Issuer: Los Angeles District Office
AG Industries LLC

Device master record [181] • Purchasing
controls [50a1] • Complaint files [198a] •
Production and process controls [70g1] •
Management responsibility [20e] • PMA

Product(s): Unspecified
Close-out letter? Not yet
Issuer: Kansas City District Office

Complaint files [198a; d] • Process
validation [75a] • Acceptance activities
[80b] • Nonconforming product [90b1] •
Inspection, measuring and test
equipment [72a]

Allergen Medical

PMA

Product(s): SERI Surgical Scaffold
Close-out letter? Not yet
Issuer: CDRH
Anybattery Inc.
Product(s): Batteries
Close-out letter? Not yet
Issuer: Minneapolis District Office

Applied Medical Distribution Center
Product(s): Suction/Irrigator; Kii Trocar;
Epix Clip
Close-out letter? Not yet
Issuer: Los Angeles District Office
Aros Surgical Instruments Corp.
Product(s): Surgical Sutures; Micro
Anastomosis Clamps
Close-out letter? Not yet
Issuer: Los Angeles District Office
Auric Enterprises Inc.
Product(s): Diack and VAC Sterilization
Monitors
Close-out letter? Not yet
Issuer: Detroit District Office

CAPA [100a] • Complaint files [198a] •
Design controls [30a] • Purchasing
controls [50] • Acceptance activities
[80b; d] • Device history record [184] •
Nonconforming product [90a] •
Management responsibility [20c] •
Quality audit [22] • Inspection,
measuring and test equipment [72a] •
Medical Device Reporting [803.17] •
PMA
CAPA [100a3] • Complaint files [198c] •
Design controls [30c; f; g] • Medical
Device Reporting [803.17a; 803.50a; a1]

Design controls [30a1; i; j] • Purchasing
controls [50b] • Document controls
[40b] • Quality audit [22] • Device master
record [181] • PMA

CAPA [100a] • Complaint files [198] •
Production and process controls [70a] •
Design controls [30] • Management
responsibility [20c]

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Banyan Medical LLC

Page 3 of 13

Design controls [30g]

Product(s): Laparoscopic Cannulas &
Trocars (specifications developer)
Close-out letter? Not yet
Issuer: New England District Office
Battle Creek Equipment Co.
Product(s): Thermo MaxHeat; Custom
Touch & Thermophore Heating Pads
Close-out letter? Not yet
Issuer: Detroit District Office
Better Health Systems Inc.
Product(s): Bio-Soft Oraliner
(specifications developer & packager)
Close-out letter? Not yet
Issuer: Denver District Office

Bio Lab-St. Joseph Corp.
Product(s): Microbiology Culture Media
Close-out letter? Not yet
Issuer: San Juan District Office

C.R. Bard Inc.
Product(s): Inferior Vena Cava Filter
Delivery Systems
Close-out letter? Not yet
Issuer: Los Angeles District Office
Cane S.p.A

Design controls [30i] • CAPA [100a] •
Complaint files [198a] • Nonconforming
product [90a] • Process validation [75a] •
Acceptance activities [80d] • Purchasing
controls [50]

Complaint files [198a] • Production and
process controls [70a] • Device history
record [184] • Purchasing controls [50] •
Acceptance activities [80b] •
Nonconforming product [90a] • CAPA
[100] • Quality audit [22] • Medical
Device Reporting [803.17] • PMA
CAPA [100a] • Process validation [75a] •
Purchasing controls [50] • Acceptance
activities [80b] • Complaint files [198e] •
Production and process controls [70c] •
Quality audit [22] • Personnel [25b] •
PMA
Complaint files [198a] • Process
validation [75a] • Acceptance activities
[80b] • Purchasing controls [50] •
Medical Device Reporting [803.50a2; b2;
b3] • PMA

Design controls [30g] • Complaint files
[198a] • CAPA [100a] • Quality audit [22]

Product(s): Infusion Pumps; Infusion
Pumps
Close-out letter? Not yet
Issuer: CDRH
Cardiac Designs Inc.
Product(s): ECG Check Application; ECG
Check Wireless Lead Cardiac Monitor
Close-out letter? Not yet
Issuer: Dallas District Office
Cenorin LLC

Design controls [30g] • Complaint files
[198] • CAPA [100a] • Medical Device
Reporting [803.17]

Corrections and Removals [806.10] •
PMA

Product(s): Washer/Pasteurizer System
Close-out letter? Not yet
Issuer: Seattle District Office
Cellestis Inc.

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/4/compilation-fda-2015... 1/29/2016

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Product(s): QuantiFERON-TB Gold
Close-out letter? Not yet
Issuer: Los Angeles District Office
Cepheid Ab

Page 4 of 13

Complaint files [198a] • Medical Device
Reporting [803.17; 803.50a2;
803.52e4] • Corrections and Removals
[806.10; 806.20]
Design controls [30i] • Quality audit [22] •
CAPA [100a] • Purchasing controls [50]

Product(s): Xpert Norovirus
Close-out letter? Not yet
Issuer: OIR/CDRH
CMP Industries LLC

Design controls [30a] • CAPA [100a] •
Corrections and Removals [806.10]

Product(s): Impak Elastic Acrylic Resin
Liquid; Impak Repair Acrylic Resin
Close-out letter? Not yet
Issuer: New York District Office
Colon Care Products of PA LLC

PMA

Product(s): Open System Colon
Hydrotherapy Device (marketer)
Close-out letter? Not yet
Issuer: CDRH
CooperSurgical Inc.

Medical Device Reporting [803.50a2] •
PMA

Product(s): Infant Heel Warmer
Close-out letter? Not yet
Issuer: New England District Office
Craftmatic Industries
Product(s): Craftmatic Adjustable HomeUse Therapeutic Bed (specifications
developer)
Close-out letter? Not yet
Issuer: Florida District Office
Customed Inc.
Product(s): Convenience Packs
Close-out letter? Not yet
Issuer: San Juan District Office

D.O.R.C. International B.V.

Purchasing controls [50a] • Complaint
files [198a; e] • Design controls [30a] •
CAPA [100a] • Quality audit [22] • Device
master record [181] • Device history
record [184] • Medical Device Reporting
[803.17]

Process validation [75a] • CAPA [100a] •
Complaint files [198e] • Production and
process controls [70d; i] • Device
packaging [130] • Storage [150a] •
Medical Device Reporting [803.17] •
PMA
PMA

Product(s): Associate 6000
Phacofragmentation System
Close-out letter? Not yet
Issuer: CDRH
Doro Inc.
Product(s): Wheeled Stretchers
Close-out letter? Not yet

CAPA [100a] • Design controls [30a] •
Complaint files [198a] • Purchasing
controls [50] • Nonconforming product
[90a] • Device master record [181] •

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Page 5 of 13

Issuer: CDRH

Inspection, measuring and test
equipment [72a] • Medical Device
Reporting [803.17]

Dr. Ashley Minas

PMA

Product(s): Interfall Hydrogel
Close-out letter? Not yet
Issuer: CDRH
Dr. Hettie Morgan

PMA

Product(s): Interfall Hydrogel
Close-out letter? Not yet
Issuer: CDRH
Elite Massagers LLC
Product(s): Elite Massagers, Massage
Belts, Back Straps & Packs
Close-out letter? Not yet
Issuer: Dallas District Office
EMcision Ltd.
Product(s): Habib EndoHPB
(specifications developer)
Close-out letter? Yes
Issuer: CDRH
Encompas Unlimited Inc.
Product(s): 50 Endo Scrub; Adult Best
Bite Block; Atypia Upper Endoscopy
Headrest
Close-out letter? Not yet
Issuer: Florida District Office
Euromi S.A.
Product(s): EVA Sp Liposuction System
Close-out letter? Not yet
Issuer: CDRH

Flextronics Electronics Technology Co.
Product(s): Patient Arrhythmia Monitors
Close-out letter? Not yet
Issuer: CDRH

Fujifilm Medical Systems USA
Product(s): Endoscopes & Endoscope
Accessories

Acceptance activities [80a] • Complaint
files [198a] • Purchasing controls [50] •
Medical Device Reporting [803.17a1a3] • PMA

CAPA [100a; b] • Complaint files [198a] •
Design controls [30i] • Document
controls [40] • Medical Device Reporting
[803.17]

CAPA [100a] • Complaint files [198a] •
Acceptance activities [80] •
Nonconforming product [90a] •
Purchasing controls [50] • Device history
record [184] • Medical Device Reporting
[803.17]

Purchasing controls [50] • Complaint
files [198a] • CAPA [100a] • Design
controls [30g] • Nonconforming product
[90a] • Inspection, measuring and test
equipment [72a] • Design controls [30e;
f] • Document controls [40] • Quality
audit [22] • Medical Device Reporting
[803.17]
Process validation [75a] • Statistical
techniques [250b] • Complaint files
[198a] • CAPA [100a] • Nonconforming
product [90b1] • Purchasing controls
[50] • Inspection, measuring and test
equipment [72a]
Design controls [30] • CAPA [100a] •
Acceptance activities [80b] • Process
validation [75a] • Complaint files [198a] •

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Close-out letter? Not yet
Issuer: CDRH

Production and process controls [70a] •
Corrections and Removals [806.10a1]

Genesis Biosystems Inc.

Production and process controls [70i] •
Device history record [184] • PMA

Product(s): DermaFrac Micro-Channeling
System
Close-out letter? Not yet
Issuer: Dallas District Office
Gentell Inc.
Product(s): Wound Dressings & Gauzes
Close-out letter? Not yet
Issuer: Philadelphia District Office
GeoTec Inc.

Management responsibility [20] • CAPA
[100a] • Complaint files [198a] • Process
validation [75a] • Device master record
[181] • Device history record [184] •
Personnel [25a]
Process validation [75a] • Device history
record [184] • CAPA [100a4]

Product(s): RFC Electrodes;
Laparoscopic Cannulas & Trocars
Close-out letter? Not yet
Issuer: New England District Office
Gottfried Medical Inc.
Product(s): Medical Support Stockings
Close-out letter? Not yet
Issuer: Cincinnati District Office

GVS Filter Technology UK Ltd.
Product(s): Air Filters & Spirometers
Close-out letter? Not yet
Issuer: CDRH

Hoya Corp.
Product(s): Endoscopes & Endoscope
Accessories
Close-out letter? Not yet
Issuer: CDRH
Inovo Inc.
Product(s): Oxygen Regulators &
Conservers
Close-out letter? Not yet
Issuer: Florida District Office
Insightra Medical Inc.

CAPA [100a] • Complaint files [198a] •
Nonconforming product [90a; b] •
Purchasing controls [50] • Design
controls [30i] • Device history record
[184] • Quality audit [22] • Management
responsibility [20c] • Document controls
[40] • Personnel [25b] • Medical Device
Reporting [803.17]
CAPA [100a; b] • Complaint files [198e] •
Process validation [75a] •
Nonconforming product [90b1; b2] •
Design controls [30g] • Purchasing
controls [50b] • Acceptance activities
[80e] • Statistical techniques [250b] •
Quality audit [22]
Design controls [30f; g] • CAPA [100a] •
Process validation [75a] • Medical
Device Reporting [803.17; 803.50a1]

CAPA [100a] • Production and process
controls [70c] • Design controls [30g] •
Purchasing controls [50] • Complaint
files [198a]

Complaint files [198a] • Medical Device
Reporting [803.17]

Product(s): Intra-Aortic Balloon
Catheters; Inguinal Hernia Implants

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Page 7 of 13

Close-out letter? Yes
Issuer: Los Angeles District Office
Insulet Corp.

Nonconforming product [90a]

Product(s): OmniPod Insulin
Management System
Close-out letter? Not yet
Issuer: New England District Office
International Medical Development
Corp.
Product(s): Gertie Marx Needles
Close-out letter? Not yet
Issuer: Denver District Office
Jian Peng Zhou

Nonconforming product [90a] •
Purchasing controls [50a3] • Acceptance
activities [80e] • Device history record
[184] • Device master record [181] •
PMA

PMA

Product(s): Dermafil (marketer)
Close-out letter? Not yet
Issuer: CDRH
LifeCell Corp.

PMA

Product(s): Strattice Reconstructive
Tissue Matrix (marketer)
Close-out letter? Not yet
Issuer: CDRH
Lusys Laboratories Inc.
Product(s): In Vitro Diagnostic Test Kits
Close-out letter? Not yet
Issuer: CDRH

Madison Polymeric Engineering
Product(s): Medical Foam & Detergent
Close-out letter? Not yet
Issuer: New England District Office
Martech Medical Products Inc.
Product(s): Unspecified
Close-out letter? Yes
Issuer: Philadelphia District Office
Medical Components Inc.

CAPA [100a] • Process validation [75a] •
Design controls [30a] • Complaint files
[198a] • Purchasing controls [50] •
Acceptance activities [80d] • Production
and process controls [70c; e] • Device
master record [181] • Management
responsibility [20b; c] • Quality audit
[22] • Document controls [40] • PMA
Production and process controls [70e] •
CAPA [100a3] • Production and process
controls [70g1]

CAPA [100b] • Complaint files [198a] •
Device history record [184] • Design
controls [30j]

CAPA [100] • Process validation [75] •
Production and process controls [70]

Product(s): Dialysis Catheters
Close-out letter? Yes
Issuer: Philadelphia District Office

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/4/compilation-fda-2015... 1/29/2016

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Medica Outlet

Page 8 of 13

PMA

Product(s): Teosyal
Close-out letter? Not yet
Issuer: CDRH
Medsource Inc.
Product(s): Orthopedic Surgical
Instrument Trays
Close-out letter? Not yet
Issuer: New England District Office
Merge Healthcare Inc.
Product(s): Software
Close-out letter? Not yet
Issuer: Minneapolis District Office
MicroAire Surgical Instruments LLC
Product(s): Endotine & Ultratine
Biodegradable Implants
Close-out letter? Not yet
Issuer: Baltimore District Office
Moor Instruments Ltd.
Product(s): Laser Doppler Blood Flow
Monitors
Close-out letter? Not yet
Issuer: CDRH
MWT Materials Inc.
Product(s): Accusorb MRI Devices
Close-out letter? Not yet
Issuer: New Jersey District Office
Natus Medical Inc.
Product(s): Seattle
Close-out letter? Not yet
Issuer: Seattle District Office
NCS Pearson

Storage [150a] • Acceptance activities
[80a] • CAPA [100a] • Management
responsibility [20]

Complaint files [198a; c] • Design
controls [30e; g] • Nonconforming
product [90a] • Corrections and
Removals [806.10]

Process validation [75a] • Production
and process controls [70i] • Medical
Device Reporting [803.17a]

Design controls [30i; g] • Nonconforming
product [90b2] • Production and process
controls [70b] • Device history record
[184] • Quality audit [22]

Complaint files [198a] • Design controls
[30j] • Device master record [181] •
Medical Device Reporting [803.17] •
Corrections and Removals [806.10a1] •
PMA
Design controls [30f; i; j] • CAPA [100a] •
Device master record [181a] • Complaint
files [198a] • Corrections and Removals
[806.10] • PMA

PMA

Product(s): Quotient ADHD Systems
Close-out letter? Not yet
Issuer: CDRH
Nephros Inc.
Product(s): Dual Stage & Single Stage
Ultrafilters; OLpur H2H Hemodiafiltration
System

Purchasing controls [50a1] • Complaint
files [198e] • Medical Device Reporting
[803.50b]

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Page 9 of 13

Close-out letter? Not yet
Issuer: New Jersey District Office
New May King Plastic Ltd.
Product(s): Massagers
Close-out letter? Not yet
Issuer: CDRH

Nuga Medical Co. Ltd.
Product(s): NM-7000, NM-2500 & NM-90
Therapeutic Heating and Massaging
Devices
Close-out letter? Not yet
Issuer: CDRH
Olympus Medical System Corp.

CAPA [100a] • Complaint files [198a] •
Design controls [30h] • Nonconforming
product [90a] • Production and process
controls [70b] • CAPA [100b] • Document
controls [40] • Production and process
controls [70g] • Personnel [25b]
Design controls [30f; g; i] • CAPA
[100b] • Complaint files [198a] •
Acceptance activities [80c] • Acceptance
activities [80b] • CAPA [100] • Medical
Device Reporting [803.17]

Medical Device Reporting [803.50a1;
803.17a3]

Product(s): Physiological Patient
Monitors and Accessories
Close-out letter? Not yet
Issuer: CDRH
Ondamed GmBH

PMA

Product(s): Ondamed System
Close-out letter? Not yet
Issuer: CDRH
OxySure Systems Inc.
Product(s): OxySure Portable Oxygen
Generator
Close-out letter? Not yet
Issuer: Dallas
Pacific Vision Institute

Nonconforming product [90a] •
Acceptance activities [80] • Design
controls [30i] • Process validation [75a] •
Complaint files [198a] • Personnel [25b] •
CAPA [100a] • Quality audit [22]

PMA

Product(s): WaveLight EX500 Excimer
Laser System
Close-out letter? No
Issuer: CDRH
Praxair Inc.
Product(s): Gas Flow Regulators
Close-out letter? Yes
Issuer: New York District Office
Quality Electrodynamics LLC
Product(s): Head, Neck, Shoulder, Knee,
Wrist & Body Coils
Close-out letter? Not yet
Issuer: Cincinnati District Office

Complaint files [198] • CAPA [100a] •
Purchasing controls [50] • Medical
Device Reporting [803.17a; 803.50a2]

Complaint files [198a] • Nonconforming
product [90b2] • CAPA [100a] •
Purchasing controls [50] • Process
validation [75a] • Production and process
controls [70a] • Design controls [30g]

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/4/compilation-fda-2015... 1/29/2016


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