Inspections, Compliance, Enforcement, and Criminal Investigations
Acuderm Inc 08-Jan-04
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
January 8, 2004
Charles Yeh, President
5370 N.W. 35th Terrace
Fort Lauderdale, Florida 33309
Dear Mr. Yeh:
During an inspection of your establishment located in Fort Lauderdale, Florida on October 8 through 22, 2003, FDA Investigators Edwin J. Gorney and Dianiris Ayala determined that your establishment is a device manufacturer(dermatophyte test medium and a smoke evacuator); that your establishment is an own-label distributor (suture kit, needle holder, thermal cautery device, hypodermic needle, electrosurgical units; skin biopsy punches, syringes, surgical blades, handles, scalpels, razor blades, scissors, nail nippers, and comedo extractors); and that your establishment is a specification developer (biopsy punches, disposable curettes, and disposable excisional scalpels) used in various surgical procedures, all of which are medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The investigators documented significant violations of the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), Part 820, and the Medical Device Reporting regulations, Title 21, CFR, Part 803. These violations cause the devices you manufacture to be adulterated within the meaning of Section 501(h)[21 U.S.C. §351(h)] of the Act.
Specifically, the investigator noted the following violations:
1. Your firm failed to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system through internal quality audits as required by 21 CFR 820.22. Quality audits failed to determine deficiencies of the quality system, the audit results were not reviewed by management and corrective actions were not effected as necessary (FDA 483, Item #13).
2. Management with executive responsibility failed to ensure that the quality policy is understood, implemented and maintained at all levels of the organization as required by 21 CFR 820.20(a). Management failed to review quality audits and to effect corrective action as necessary to ensure the quality system is in compliance with all quality requirements (FDA 483, Item #12).
3. Your firm failed to validate a process whose results cannot be fully verified by subsequent inspection or test as required by 21 CFR 820.75(a). Your firm did not validate the package sealing process for devices intended to be sterilized and there is no assurance that the radiation sterilization process has been validated (FDA 483, Item #5).
4. Your firm failed to implement corrective and preventive action procedures necessary to address the results of investigations of the causes of nonconformities relating to product, processes, and the quality system as required by 21 CFR 820.100(a)(2). The causes of nonconformities and the actions needed to correct or prevent their recurrence, and the distribution of nonconforming product, were not investigated and documented, e.g., [redacted] vials of lot #960603 were rejected due to microbial contamination but the remaining vials were released and distributed on June 26th and 27th, 2003 without investigation; six complaints were received concerning microbial contamination of ACU-DTM®(Dermatophyte Test Medium) lot #970603 that was distributed with no investigation; consumer complaints concerning needle hubs getting clogged were not investigated (FDA 483, Item #1).
5. Your firm failed to implement established procedures for receiving, reviewing, and evaluating complaints as required by 21 CFR 820.198(a). All complaints were not reviewed and evaluated as necessary to determine their validity or the root cause of the nonconformities, e.g., eight complaints regarding microbial contamination of the ACU-DTM® lots #960603 and 970603 were not fully evaluated or investigated; and nine complaints received in 2003 cited the quality and performance of plastic and metal hubs that were not investigated (FDA 483, Item #2)
6. Your firm failed to maintain data, including purchasing agreements, to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50(b). There are no records documenting that contract manufacturers and suppliers have been qualified to assure that products or services supplied meet all quality requirements or that contract manufacturers will notify you of product or service changes (FDA 483, Item #s 3&4).
7. Your firm failed to conduct operations in accordance with established process controls and standard operating procedures as required by 21 CFR 820.70(a)(1). Packaging work instructions for the ACU-SCISSORS® and ACU-SUTURE® require heat sealer machine settings at #4 and #6, respectively. However, according to machine operators, the sealer machine is always set on #5 no matter what device is being packaged (FDA 483, Item #7).
8. Your firm failed to monitor and control production processes to ensure that the device conforms to its specifications as required by 21 CFR 820.70(a)(2). Work instructions and procedures covering the package sealing process, which has been in use for 10 years, have not been validated and are not monitored to ensure the device packaging conforms to specifications. The contracted radiation sterilization process does not address specifications for bioburden studies, loading configuration, placement of dosimeters, and resterilization; which are required for validation to ensure the process meets specifications (FDA 483, Item #6).
9. Your firm failed to establish and maintain procedures for the identification, documentation, validation, review, and approval of design changes before their implementation as required by 21 CFR 820.30(i). Design changes to the ACU E-VAC® and a suture kit made to correct documented failures of the devices in the field were not approved prior to implementation (FDA 483; Item #8)
10. Your firm failed to control document approval including the date and signature of the individual approving the document as required by 21 CFR 820.40(a). Review of engineering drawings for the ACU E-VAC® and the ACU-PUNCH® found they were not signed and dated as approved prior to their issuance and implementation. (FDA 483, Item #9).
11. Your firm failed to provide adequate resources, including trained personnel, to conduct activities assessing quality requirements as required by 21 CFR 820.20(b)(2). The individual tasked to oversee quality assurance and finished product release is not adequately trained and does not have the required knowledge and expertise to conduct these functions (FDA 483, Item #10).
12. Your device master records fail to include or refer to the location of production and process specifications as required by 21 CFR 820.181(b). There is no documentation that refers to the location of device and process specifications and packaging/labeling specifications for own-label devices made under contract or for devices repacked and relabeled at your facility (FDA 483, Item #11).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. 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, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2), any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751 (407) 475-4728.
Emma R. Singleton
Director, Florida District