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warning letter roundup .pdf

Original filename: warning letter roundup.pdf
Title: https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/
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Printed by Mr. Norm Rabin, Maetrics LLC

Warning Letter Roundup & Recap –
January 26, 2016
Regulatory Correspondence / Word Count: 307 / Article # 01160201008 /
Posted: January 26 2016 5:05 PM

Executive Summary
Quality system violations identified at maker of A/C-powered illuminators and
manufacturer of ceramic dental brackets. Two device warning letters were
listed by FDA this week.

Topics Covered in
this Article
Click a keyword for related
General Topics
quality assurance
warning letter
Post-Market Regulation
Pre-Market Regulation
Medical Devices

This chart lists warning letters released by FDA on Jan. 26, 2016. If an
inspection led to the warning letter, the location of the inspected facility and
dates of inspection are noted; otherwise, the location of the warning letter
recipient is listed.


IsoLux LLC
Warning letter
Jan. 8, 2016
Location: Naples, Fla.
Inspection dates: Nov. 4-6,

Manufacturer of A/C-powered illuminators cited for
QS reg violations. CAPA procedures weren't
established; for example, CAPA records didn't include
documentation of corrective actions, and verification
or validation activities. Purchasing control procedures
weren't adequate to qualify a supplier of fiber optic
cables. Procedures also weren't established for
incoming product and design change. There was no
design history file for the firm's 1180 XSB Xenon
Light Source device, and a review of the DHF didn't
include documented evidence that the design was
approved for transfer to production. The company's
response to the FDA-483 was deemed inadequate.
[Issued by Florida District Office]




Page 2 of 2

Warning letter
Dec. 9, 2015
Location: Port Richey, Fla.
Inspection dates: Aug. 31Sept. 1, 2015

QS reg violations identified at manufacturer of
ceramic dental brackets. Process validation activities
weren’t conducted. CAPA procedures weren't
established. Further, procedures weren't established
to ensure routine calibration, inspection and
maintenance of manufacturing equipment, particularly
optical comparators, micrometers and dial calipers.
Acceptance activities weren't conducted for incoming
raw component, and records documenting the
acceptance of incoming components weren't
maintained. Device history records weren't
maintained. Production and process control activities
weren't conducted. Quality audits weren't performed.
Finally, quality system procedures and instructions
weren't established. The firm's response to the FDA483 was deemed inadequate. [Issued by Florida
District Office]

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.
Printed by Mr. Norm Rabin, Maetrics LLC

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