FDA WARNING_LETTER - GS Medical Packaging Inc - January 31, 2013

On January 28-31, 2013, an FDA inspection of GS Medical Packaging Inc. in Mississauga, Canada, identified that their Professional's Choice Sterilization Pouch and Steril-Peel Sterilization Pouch devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's February 22, 2013, response was deemed inadequate.

Key violations include: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a)):** The firm's SOP 7.3.0, Rev A, was incomplete, lacking details on design transfer, design history file, specific forms, review frequency, and retrospective review. 2. **Failure to evaluate complaints for MDR reportability (21 CFR 820.198(a)(3)):** SOP 8.5.3, Rev. B, and other forms did not capture whether complaints required Medical Device Reporting (MDR) evaluation, and no retrospective review was conducted. 3. **Failure to establish and maintain acceptance activity procedures (21 CFR 820.80(a)):** Procedures for finished product testing, including sampling, parameters, acceptance criteria, and documentation, were