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Dental Firm Texas 8Jan16 .pdf


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Department of Health and Human Services

Public Health Service
Food and Drug Administration
Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204·3128

October 30, 2015
Ref: 2016-DAL-WL - 02
WARNING LETTER
VIA UNITED PARCEL SERVICE
Son Tran, President
CrystalBraces Limited Liability Company
2515 McKinney Avenue, Suite 940
Dallas, Texas 75201
Dear Dr. Tran:
During concurrent inspections of your firms located at 2515 McKinney Avenue, Dallas, Texas and
3211 W. Northwest Highway, Suite 200, Dallas, Texas on September 16-23, 2015, the United States
Food and Drug Administration (FDA) determined that your firm manufactures, markets, and
distributes the CrystalBraces dental aligner. Under section 201(h) of the Federal Food, Drug, and
Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended
for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or
prevention of disease, or to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of
the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their
manufacture, packing, storage, or installation are not in conformity with the current good
manufacturing practice requirements of the Quality System regulation found at Title 21, Code of
Federal Regulations (CFR), Part 820. Your firm’s response dated October 14, 2015 to the Form
FDA 483 (FDA 483) states you will provide a full response by October 30, 2015. Because this
response was not received within fifteen business days of issuance of the FDA 483, the response

will be evaluated along with any other written material provided in response to the violations cited in
this Warning Letter. These violations include, but are not limited to, the following:
1.

Failure to establish and maintain procedures to control the design of the device in order to

ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
Your firm has written and approved several design control procedures for establishing and
documenting design inputs, design outputs, design reviews, design verification, design validation
and design transfer. Each of these procedures have an effective date of June 18, 2015. However,
during the inspection, your firm could not provide any records to demonstrate these procedures have
been implemented. Your firm has not documented the design inputs, outputs, reviews, verifications,
validations, or design transfer for your CrystalBraces dental aligner.
2.

Failure to validate computer software for its intended use according to an established protocol

when computers or automated data processing systems are used as part of production or the quality
system, as required by 21 CFR 820.70(i).
a.

Your firm uses “(b)(4)” and “(b)(4)” to take (b)(4) of patients’ teeth and determine the desired

movement pattern to generate your dental aligners. Your firm has not validated this software, you
use as part of your production activities, for its intended use.
b.

Your firm uses “(b)(4)” and “(b)(4)” to convert (b)(4) of patients’ impressions to file types

compatible with the (b)(4) used to manufacture the molds for your dental aligners. You have not
validated these software programs for their intended use.
3.

Failure to develop, conduct, control, and monitor production processes to ensure that a device

conforms to its specifications, as required by 21 CFR 820.70(a).
Your firm has not established procedures to control your (b)(4) process used to create the mold for
the dental aligners or the (b)(4) used to mold and harden the finished devices. Your firm does not
have any procedures that provide instructions for the methods used to control manufacturing.
4.

Failure to ensure that when the results of a process cannot be fully verified by subsequent

inspection and test, the process shall be validated with a high degree of assurance and approved
according to established procedures, as required by 21 CFR 820.75(a).
Your firm uses a (b)(4) to manufacture your dental aligners by (b)(4) and (b)(4) dental plastic over
a (b)(4)mold. Your firm has not validated this process.

5.

Failure to maintain device master records (DMR’s) and to ensure that each DMR is prepared

and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.
Your firm has not established a DMR for your CrystalBraces dental aligners that at least include or
reference device specifications, production process specifications, quality assurance procedures, or
packaging and labeling specifications.
6.

Failure to establish and maintain procedures to ensure that all purchased or otherwise received

product and services conform to specified requirements, as required by 21 CFR 820.50.
a.

Your firm’s “Purchasing” procedure, PPC-107-01 revision 1 dated June 18, 2015, states your

firm will generate an approved supplier list per your Supplier Qualification procedure. However, your
firm has not established a Supplier Qualification procedure or generated an approved supplier list.
b.

Your firm has not documented any supplier qualifications for any of your suppliers. Your firm has

a critical supplier of your dental plastic used in the manufacturing of your dental aligners and you
have not conducted any qualification of this supplier to ensure it can provide product that meets your
requirements.
c.

Your firm has not established supplier agreements requiring suppliers to notify your firm of any

changes to the products they provide.
7.

Failure to establish and maintain procedures to ensure that device history records (DHR’s) for

each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance
with the device master record (DMR) and the requirements of this part, as required by 21 CFR
820.184.
Your firm’s “Device History Record” procedure DOC-108-01 revision 1 dated June 18, 2015, requires
inspections, tests, nonconformances, final inspection, the identification of all measuring or test
equipment, or the final QA approval for your devices. However, your firm has not established or
maintained any DHR’s for your CrystalBraces medical devices.
8.

Failure to establish and maintain procedures for acceptance of incoming product, as required by

21 CFR 820.80(b).
Your firm’s “Purchasing” procedure PPC-107-01 revision 1 dated June 18, 2015, states product that
is received must be inspected per the “Receiving Inspection Procedure”. However, your firm does
not have a documented “Receiving Inspection Procedure” nor have you conducted and

documented any inspections or tests for any of your incoming components used in the
manufacturing of your device.
A follow up inspection will be required to assure that corrections and/or corrective actions are
adequate.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to
promptly correct these violations may result in regulatory action being initiated by the FDA without
further notice. These actions include, but are not limited to, seizure, injunction, and civil money
penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices
so that they may take this information into account when considering the award of
contracts. Additionally, premarket approval applications for Class III devices to which the Quality
System regulation violations are reasonably related will not be approved until the violations have
been corrected. Requests for Certificates to Foreign Governments will not be granted until the
violations related to the subject devices have been corrected.
In addition, we remind you, as identified in the Acknowledgement Letter submitted to your firm by
FDA on September 16, 2015, you may not place this CrystalBraces dental aligner device into
commercial distribution until you receive a letter from FDA allowing you to do so.
Please notify this office in writing within fifteen business days from the date you receive this letter of
the specific steps your firm has taken to correct the noted violations, as well as an explanation of
how your firm plans to prevent these violations, or similar violations, from occurring again. Include
documentation of the corrections and/or corrective actions (which must address systemic problems)
that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over
time, please include a timetable for implementation of those activities. If corrections and/or
corrective actions cannot be completed within fifteen business days, state the reason for the delay
and the time within which these activities will be completed. Your firm’s response should be
comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Dallas District Office, 4040 North Central Expressway, Suite
300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact:
Jeff R. Wooley, Compliance Officer at 214-253-5251.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at
your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and
regulations administered by FDA. The specific violations noted in this letter and in the Inspectional
Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious
problems in your firm’s manufacturing and quality management systems. Your firm should

investigate and determine the causes of the violations, and take prompt actions to correct the
violations and bring the products into compliance.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director

Cc:
Phong N. Tran, Vice President
CrystalBraces Limited Liability Company
2515 McKinney Avenue, Suite 940
Dallas, Texas 75201
Tom Brinck, Manager
Drugs and Medical Devices Group
Texas Department of State Health Services
8407 Wall Street, S-124
Austin, Texas 78714

2015

Page Last Updated: 12/28/2015


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