# FDA WARNING_LETTER - Hubei Weikang Protective Products Co., Ltd. - April 04, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/hubei-weikang-protective-products-co-ltd/ba8c6c50-a5e3-4144-8ea7-41e637f5da40

> FDA WARNING_LETTER for Hubei Weikang Protective Products Co., Ltd. on April 04, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hubei Weikang Protective Products Co., Ltd.
- Inspection Date: 2013-04-04
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On August 12, 2013, the FDA issued a Warning Letter to Hubei Weikang Protective Products Co., Ltd. following an inspection from April 1-4, 2013, which found their surgical masks to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's July 16, 2013, response to the FDA 483 was not reviewed due to late submission.

Violations included:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** The CAPA procedure (WK/QR-0-13) was inadequate, lacking non-conformance data collection by (b)(4) and not requiring verification/validation of corrective actions. The firm's April 25, 2013, response was deemed inadequate as objective evidence of implementation and English translation of the CAPA procedure were not provided.
2.  **Failure to establish and maintain design transfer procedures (21 CFR 820.30(h)):** No documentation of design transfer activities was provided. The firm's April 25, 2013, response was inadequate as the new SOP was still in development

## Related Documents

- [WARNING_LETTER - 2015-06-04](https://www.globalkeysolutions.net/records/warning_letter/hubei-weikang-protective-products-co-ltd/5377e81a-79e7-43bd-aa35-d9aed94f361e)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/hubei-weikang-protective-products-co-ltd/74a24d5e-4e41-4a00-8ddf-e43719c56428

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