# FDA WARNING_LETTER - Henan Kangdi Medical Devices Co. Ltd - March 07, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/henan-kangdi-medical-devices-co-ltd/b1c244ec-7c14-4370-a2a7-b8a61907799c

> FDA WARNING_LETTER for Henan Kangdi Medical Devices Co. Ltd on March 07, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Henan Kangdi Medical Devices Co. Ltd
- Inspection Date: 2019-03-07
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Henan Kangdi Medical Devices Co. Ltd. following a March 4-7, 2019, inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm manufactures "Capsicum Plaster HOT" and "1st Medx-Patch With 4% Lidocaine," which are also deemed unapproved new drugs.

Key violations include:
1.  **Failure to test finished drug products:** The firm did not test each batch for identity and strength of active ingredients before release (21 CFR 211.165(a)). The response was inadequate, lacking details on third-party testing, methods, and retrospective testing of distributed batches.
2.  **Failure to test components:** The firm did not test incoming APIs and raw materials for identity, purity, strength, or validate supplier analyses (21 CFR 211.84(d)(1) and (2)). This was a repeat observation from a 2016 inspection. The response was inadequate, not committing to cease manufacturing or addressing risk assessment for distributed products.
3.  **Lack of stability testing:** The firm failed to establish an adequate stability program to support product expiration dates (21 CFR 211.137(a)). The response lacked stability protocols, quality attributes, acceptance criteria, and real-time testing assurance.

The FDA noted inadequate quality

## Related Documents

- [483 - 2019-03-07](https://www.globalkeysolutions.net/records/483/henan-kangdi-medical-devices-co-ltd/77afab47-0250-4d4b-a4b1-eddfd0e3d351)

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