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

Source: https://www.keypedia.com/records/warning_letter/gs-medical-packaging-inc/1c9928f9-aa44-40fd-ad7c-e31f4ec0f70a

> FDA WARNING_LETTER for GS Medical Packaging Inc on January 31, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: GS Medical Packaging Inc
- Inspection Date: 2013-01-31
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/gs-medical-packaging-inc/1bba0ec9-8982-4ac3-b73f-a4ea2b2a3e9e

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7