Inspections, Compliance, Enforcement, and Criminal Investigations
Retro-Tech, LLC 19-Mar-08
Department of Health and Human Services
Public Health Service
March 19, 2008
RETURNED RECEIPT REQUESTED
Mr. James D. Cox, Co-owner and Managing Member
P.O. Box 796937
Dallas, Texas 75379
Dear Mr. Cox:
During an inspection of your firm located at 7120 Nicki Court, Dallas, Texas 75252, on January 11, 14, 23, and 30, 2008, and February 1, 2008, an investigator from the United States Food and Drug Administration (FDA or Agency) determined that your firm, a specification developer, manufactures the Retro-Tech™ RTD Bacteriostatic Wound Dressing that is indicated for moderately to heavily exuding and partial to full thickness wounds as stated in your firm's 510(k) K060832. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.
This inspection revealed that the device is 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, its manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820.
The FDA investigator issued the observations, which are listed on the Form FDA 483 (List of Inspectional Observations), to you at the end of the inspection on February 1, 2008. You verbally promised to correct some of the inspectional observations as annotated on the Form FDA 483. The violations include, but are not limited to, the following:
Quality System Violations
1. Failure of the management with executive responsibility to ensure that an adequate, and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 C.F.R. § 820.20. FDA 483 Item 1. Specifically, your firm has not established and approved quality system procedures that delineate the specific responsibilities and manufacturing operations for each of your [redacted] contract manufacturing facilities during your design development of the wound dressings, production, and prior to receiving your first production lot from the contract manufacturer, packager, and sterilizer. During the Agency's inspection, you drafted a number of the manufacturing. procedures but did not review and approve them for adequacy.
2. Failure to establish and maintain adequate procedures for validating the device design to ensure that the device conforms to user needs and intended uses, that acceptance criteria are established prior to performing validation activities, that design risk analysis is conducted and documented, that design testing is conducted under actual or simulated use conditions, and that the design testing results are documented, as required by 21 C.F.R. § 820.30(g). FDA 483 Item 6. Specifically:
a. Your firm has not established device design risk analysis procedures, conducted a design risk analysis, and documented the results of the design risk analysis.
b. Your wound dressings are medicated with three anti-microbial drugs as listed on the device labeling, packaged, and then [redacted] irradiated. However, your firm has not evaluated and documented your evaluation of the [redacted] irradiation effect on the anti-microbial drugs.
c. Your firm has not conducted stability testing to determine the expiration dating for the Retro-Tech RTD wound dressings containing the embedded anti-microbial drugs or provided a credible scientific rationale for not doing so.
3. Failure to establish and maintain device design plans prior to implementing the device design, as required 21 C.F.R. § 820.30(b). FDA 483 Item 2. Specifically, your firm has not established, approved, and maintained a written design plan that describes specific design development activities to be performed, interfaces with different groups or activities that provide input to the design development process, and their responsibility for implementation.
4. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's development, as required by 21 C.F.R. § 820.30(e). FDA 483 Item 5. Specifically, your firm has not maintained design review agenda, design review results or meeting minutes with the contract manufacturer, contract packager, and contract sterilizer during your firm's design development of the Retro-Tech RTD wound dressings.
5. Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 C.F.R. § 820.30(i). FDA 483 Item 3. Specifically, your firm has not established design change procedures to initiate, review, test, approve, and document pre- and post-production design changes. Your contract manufacturer's [redacted] Product Specification Manufacturing Procedure" documented a new product design on 6/8/05 and two subsequent design changes on 3/30/06 and 8/7/07. Your firm has not conducted and documented its review, design verification testing or design validation, and documented its approval of these design changes before authorizing your contract manufacturing facilities to start production.
6. Failure to establish and maintain a device design history file for each type of device to include or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements of 21 C.F.R. § 820, as required by 21 C.F.R. § 820.300). FDA 483 Item 4. Specifically, your firm failed to request and obtain specific design development records for your RTD brand of the wound dressings from the contract manufacturing facilities or establish your own design records in your device design history file which include the design plan, design inputs/outputs, design reviews, design verification or validation, design transfer, and design changes.
7. Failure to establish and maintain procedures to ensure that the device history record (DHR) for each batch, lot, or units are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 C.F.R. § 820.184. FDA 483 Item 9 and 11. Specifically:
a. Your firm has not established and maintained procedures to define (a)(1) what specific acceptance criteria, quality attributes or specifications are to be inspected, rejected or accepted, and documented by your contract manufacturing facilities prior to delivering the wound dressings to your firm; (a)(2) your firm's receiving acceptance activities; (a)(3) what acceptance records are to be provided by your contract manufacturing facilities for your review and approval; and (a)(4) acceptance records of your firm's inspection or verification of the incoming wound dressings.
b. Your firm has not maintained a complete device history record for the recent lot of the wound dressings received in September 2007, including the dates of manufacturing, batch records of the anti-microbial drugs, records of inspection or testing of the wound dressings being manufactured at the contract manufacturer and subsequently packaged at the contract packager, and records of your receiving inspection and labeling examination of the incoming packaged wound dressings.
8. 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 C.F.R. § 820.50. FDA 483 Item 7 and 8. Specifically:
a. Your unsigned Purchasing Procedure, Revision A, DCN 019, dated 1/17/08, written during the inspection is deficient in that it does not require evaluating and selecting potential suppliers, contractors, and consultants, and notifying your firm of changes in the product or services. Additionally, your firm did not document its evaluation results of the ability of the contract manufacturing facilities to meet your firm's requirements, including quality requirements.
b. Your firm has not approved and maintained a list of purchasing data or purchasing documents that clearly describe or reference specific product requirements, specifications, and quality expectations or requirements for your wound dressings being manufactured at the contract manufacturing facilities (contract manufacturer, packager, and sterilizer).
Medical Device Reporting (MDR) Violation
Our inspection also revealed that your firm's wound dressings are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 C.F.R. § 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to develop, maintain, and implement written MDR procedures, as required by 21 C.F.R. § 803.17. FDA 483 Item 12. Specifically, your firm did not have written medical device reporting procedures for receiving, evaluating, and submitting MDR reports to the FDA.
Responding to This Warning Letter
You 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/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 (21 C.F.R. Part 820) deviations 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Reynaldo R. Rodriguez
Dallas District Director
Mr. James D, Cox, Co-owner and Managing Member
Mr. Kevin Marshall, Co-owner and Managing Member
7120 Nicki Court
Dallas, Texas 75252-6125
Mr. Thomas A. Jarvis, Co-owner and Managing Member