# FDA WARNING_LETTER - Lac-Mac Limited - November 06, 2014

Source: https://www.globalkeysolutions.net/records/warning_letter/lac-mac-limited/934728be-3a7f-4b4f-951e-77ea5eb3f444

> FDA WARNING_LETTER for Lac-Mac Limited on November 06, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lac-Mac Limited
- Inspection Date: 2014-11-06
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On November 3-6, 2014, an FDA inspection of Lac Mac, Ltd. in London, Ontario, identified that their surgical gowns, sterile wraps, and surgical drapes are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's November 25, 2014, response to the FDA 483 was deemed inadequate.

Key violations include:
1.  **Design Control (21 CFR 820.30(a)):** Failure to establish and maintain procedures ensuring design input/output, verification, validation, review, changes, and transfer are documented. DHFs lacked this information. The firm's revised procedures were insufficient without a retrospective DHF review.
2.  **CAPA (21 CFR 820.100(a)):** Inadequate CAPA procedures lacking requirements for data analysis, investigation, action identification, verification/validation, implementation, information dissemination, management review submission, and documentation. Specific CAPA records (137, 138, 143, 144) lacked investigation results, validation, and implementation dates. CAPA 138, concerning barcode complaints, lacked documented verification/validation of corrective actions. The firm's revised CAPA

## Related Officers

- [Jan B. Welch](https://www.globalkeysolutions.net/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)

Company: https://www.globalkeysolutions.net/companies/lac-mac-limited/13e228db-4e44-4128-aa93-b5c8d1dd324a

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