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Warning letter issued to a Manufacturer of Medicinal Products "Chan Yat Hing Medicine Factory" in Hong Kong by FDA

The FDA issued a warning letter to a manufacturer of medicinal products "Chan Yat Hing Medicine Factory " in Hong Kong on 15 December 2015.


The FDA investigator identified significant violations from current good manufacturing practice (CGMP) for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.


Investigator observed specific CGMP violations during the inspection, including, but not limited to, the following:


The FDA issued a warning letter to a manufacturer of medicinal products "Chan Yat Hing Medicine Factory " in Hong Kong on 15 December 2015. The FDA investigator identified significant violations from current good manufacturing practice (CGMP) for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.
Investigator observed specific CGMP violations during the inspection, including, but not limited to, the following:
1) The facility failed to test finished batches of drug products for the identity and strength of active ingredients (21 CFR 211.165(a)).
2) The facility failed to ensure the identity of components, including active ingredients and excipients from various suppliers (21 CFR 211.84(d)(1) and (2)).
3) The facility had no data to demonstrate that the chemical and physical properties of products remain acceptable throughout their shelf life (21 CFR 211.166(a)).
4) The facility failed to establish adequate written procedures for production and process controls, including validation protocols and reports, designed to assure that your drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
5) The facility failed to establish written responsibilities and procedures applicable to the quality control unit, including the review of out-of-specification results and customer complaints (21 CFR 211.22(d)).
6) The facility failed to calibrate and maintain written records for the scale used to weigh components, including active ingredients, prior to their addition into the manufacturing process (21 CFR 211.68(a)).

The FDA has not received a response from the firm concerning CAPA measures. As a result, the firm has now been placed on Import Alert with immediate effect.


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