Inspections, Compliance, Enforcement, and Criminal Investigations
Superior Uniform Group, Inc. 23-Oct-03
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
October 23, 2003
Superior Uniform Group, Inc.
10055 Seminole Boulevard
Seminole, Florida 33772
Dear Mr. Benstock:
During an inspection of your establishment located in Seminole, Florida, on August 4-6, 2003, an investigator from the United States Food and Drug Administration (FDA) determined that your establishment is a specification developer of surgical and general hospital uniforms and patient apparel. These products are used by health practitioners and patients to protect both surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials and are devices, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(h)].
The investigator documented significant violations from 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)] and misbranded within the, meaning of Section 502(t)(2) [21 U.S.C. §352(t)(2)] of the Act.
Specifically, the investigator noted the following violations:
1. Management with executive responsibility has not ensured that an adequate and effective quality system has been implemented and maintained at all levels of the organization, and dates of management reviews are not documented, as required by 21 CFR 820.20. The investigator determined that your quality system was implemented in July 2003; however, the quality plan lacks management review pursuant to 21 CFR 820.20(c) and corrective and preventive action (CAPA) procedures pursuant to 21 CFR 820.100 [FDA 483, Items #1 & 6].
2. Your firm failed to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). The investigator determined that you have not established written CAPA procedures pursuant to 21 CFR 820.100(a) and 21 CFR 820.3(k) [FDA 483, Item #2].
3. Your firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198. The investigator determined that complaints are not evaluated to determine the cause of a product failure [FDA 483, Item #5].
4. Your firm's design end development plan has not been fully implemented; as required by 21 CFR 820.30(b). Your firm's design system was approved and implemented in February 2003; however, records documenting changes to medical devices were not available. A change in the fabric for the Mega-Shield product used for barrier protection was not documented after the design change in 1993 [FDA 483, Item #3].
5. Your firm failed to document the dates and names of individuals performing, calibration of inspection; measurement and test equipment, as required by 21 CFR 820.72(b)(2) [FDA 483, Item #8].
6. Your firm failed to retain manufacturing and quality control records for a period of time equivalent to the design and expected life of the device but in no case less than two years from the date of release for commercial distribution, as required by 21 CFR 820.180(b). Manufacturing records were maintained for one year or less, including those for surgical gowns, style 562 [FDA 483, Item #9].
7. Your firm failed to establish and maintain written MDR procedures, as required by 21 CFR 803.17 [FDA 483, Item #4].
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.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared or approved 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.
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.
Director, Florida District