# China NMPA Inspection - Guangxi Dahai Sunshine Pharmaceutical Co., Ltd. (formerly Beihai Sunshine Pharmaceutical Co., Ltd.) - December 29, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-dahai-sunshine-pharmaceutical-co-ltd-formerly-beihai-sunshine-pharmaceutical-co-ltd/422d4e0d-88bf-4f9d-85f3-df41f31042dc/
Source feed: China

> China NMPA unannounced inspection for Guangxi Dahai Sunshine Pharmaceutical Co., Ltd. (formerly Beihai Sunshine Pharmaceutical Co., Ltd.) published December 29, 2017. An unannounced inspection of Guangxi Dahai Yangguang Pharmaceutical Co., Ltd. (formerly Beihai Yangguang Pharmaceutical Co., Ltd.) was conducted from 

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangxi Dahai Sunshine Pharmaceutical Co., Ltd. (formerly Beihai Sunshine Pharmaceutical Co., Ltd.)
- Company Name: Guangxi Dahai Sunshine Pharmaceutical Co., Ltd. (formerly Beihai Sunshine Pharmaceutical Co., Ltd.)
- Publication Date: 2017-12-29
- Product Type: Drugs
- Summary: An unannounced inspection of Guangxi Dahai Yangguang Pharmaceutical Co., Ltd. (formerly Beihai Yangguang Pharmaceutical Co., Ltd.) was conducted from October 17-19, 2017, by the State Food and Drug Administration. The inspection, prompted by a drug sampling, revealed severe regulatory non-compliance concerning the production of gentamicin sulfate tablets. Key issues included a material distribution error in November 2016, where an incorrect batch of gentamicin sulfate raw material was used, and the company's subsequent failure to take timely corrective measures. Instead, the company resorted to extensive document forgery, creating false invoices, sample records, inventory ledgers, inspection reports, and batch production records for four batches of gentamicin sulfate tablets (batch numbers 161103, 161104, 161105, 161106) to conceal the initial mistake. Additionally, a separate batch of gentamicin sulfate tablets (batch 150801) failed to meet the quality standards of the Chinese Pharmacopoeia. These actions were deemed serious violations of drug administration laws and regulations. Consequently, the company's GMP certificate was revoked, a recall of all affected gentamicin sulfate tablets was mandated, and an investigation was initiated to hold the company and responsible individuals accountable.

Company: https://www.globalkeysolutions.net/companies/guangxi-dahai-sunshine-pharmaceutical-co-ltd-formerly-beihai-sunshine-pharmaceutical-co-ltd/573b811e-9df8-4f3c-99a0-10175f3d4e33/