# China NMPA Inspection - Anhui Aikeer Pharmaceutical Co., Ltd. - August 26, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/anhui-aikeer-pharmaceutical-co-ltd/de397e5f-2e74-40d1-b12a-05cafe58c86f/
Source feed: China

> China NMPA unannounced inspection for Anhui Aikeer Pharmaceutical Co., Ltd. published August 26, 2016. Anhui Aikeer Pharmaceutical Co., Ltd. underwent an unannounced GMP inspection by the China Food and Drug Administration (CFDA) from April 23-25, 2016.

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Anhui Aikeer Pharmaceutical Co., Ltd.
- Company Name: Anhui Aikeer Pharmaceutical Co., Ltd.
- Publication Date: 2016-08-26
- Product Type: Drugs
- Summary: Anhui Aikeer Pharmaceutical Co., Ltd. underwent an unannounced GMP inspection by the China Food and Drug Administration (CFDA) from April 23-25, 2016. The inspection revealed serious deficiencies in the company's compliance with the "Good Manufacturing Practice for Pharmaceuticals" (2010 revision). Key violations included the unauthorized alteration of production processes for eye drop products, specifically changing from non-aseptic to aseptic methods without regulatory approval. To conceal this, the company fabricated extensive batch production records, including sterilization data for acyclovir and ribavirin eye drops. Furthermore, the authorized quality officer and other key quality management personnel failed to adequately perform their duties, demonstrating a lack of relevant experience and insufficient oversight. Quality control processes were found to be inadequate, with issues such as unvalidated analytical methods and chaotic management within the aseptic testing laboratory. Significant problems were also identified in aseptic operations and quality control for eye drops, including the absence of packaging integrity verification, insufficient validation of sterilization processes (e.g., ethylene oxide), inadequate disinfection procedures for sterilized components entering clean areas, and a lack of proper environmental monitoring in cleanrooms. Issues with sterilization filter validation and the absence of quality standards for compressed air used in filling operations were also noted. As a result of these findings, the State Food and Drug Administration mandated the Anhui Provincial Food and Drug Administration to revoke the company's eye drop GMP certificate, supervise the recall of all affected marketed products, and launch a formal investigation.

Company: https://www.globalkeysolutions.net/companies/anhui-aikeer-pharmaceutical-co-ltd/a3d6ad45-cb99-4b2e-b77e-2ebe9cd09dff/