# China NMPA Inspection - Shijiazhuang Green Pharmaceutical Co., Ltd. - August 26, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/shijiazhuang-green-pharmaceutical-co-ltd/cc77a946-96d9-41f3-8637-56c74dd679a6/
Source feed: China

> China NMPA unannounced inspection for Shijiazhuang Green Pharmaceutical Co., Ltd. published August 26, 2016. A follow-up inspection by the China Food and Drug Administration (CFDA) from April 23-25, 2016, revealed critical non-compliance at Shijiazhuang Green

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Shijiazhuang Green Pharmaceutical Co., Ltd.
- Company Name: Shijiazhuang Green Pharmaceutical Co., Ltd.
- Publication Date: 2016-08-26
- Product Type: Drugs
- Summary: A follow-up inspection by the China Food and Drug Administration (CFDA) from April 23-25, 2016, revealed critical non-compliance at Shijiazhuang Green Pharmaceutical Co., Ltd. Significant deficiencies were identified across several areas of drug manufacturing practice, indicating a failure to adhere to the "Good Manufacturing Practice for Pharmaceuticals" (2010 revision).

The main violations included severe laboratory data reliability issues. Inspectors found unauthorized modifications to workstation system times on high-performance liquid chromatographs (HPLC), with evidence of time adjustments to falsify data creation dates and retroactively conduct stability tests for chloramphenicol eye drops.

Furthermore, the inspection uncovered a critical loss of original record data, making product traceability impossible. Original inspection records for a batch of chloramphenicol raw material were missing, and instrument usage logs did not corroborate reported inspection dates. Data from a gas chromatograph workstation for 2014 was also missing and unbacked-up.

Finally, computerized analytical instruments, including HPLCs, gas chromatographs, and atomic absorption spectrophotometers, lacked proper authorized management, as operators could modify workstation time settings, compromising data integrity.

As a result, the State Food and Drug Administration (SFDA) mandated the revocation of the company's GMP certificate for eye drops, ordered a recall of all marketed products, and initiated a formal investigation into the identified breaches.

Company: https://www.globalkeysolutions.net/companies/shijiazhuang-green-pharmaceutical-co-ltd/8d5c8740-1aef-4f9f-b244-656e561e18e3/