Inspections, Compliance, Enforcement, and Criminal Investigations

CrystalBraces, LLC. 10/30/15

  

Department of Health and Human Services logoDepartment 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

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