# China NMPA Drug Inspection - GlaxoSmithKline Pharmaceuticals (Suzhou) Co., Ltd. - Lamivudine tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/glaxosmithkline-pharmaceuticals-suzhou-co-ltd/925a0fc7-321a-427f-980e-f0a4d6097739/
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> China NMPA drug inspection for GlaxoSmithKline Pharmaceuticals (Suzhou) Co., Ltd. published October 31, 2019. Drug: Lamivudine tablets. The Hubei Provincial Food and Drug Administration issued its Fourth Quarter 2012 "Hubei Provincial Drug Quality Bulletin

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Notice from the Hubei Provincial Food and Drug Administration on Issuing the Fourth Quarter 2012 "Hubei Provincial Drug Quality Bulletin"
- Company Name: GlaxoSmithKline Pharmaceuticals (Suzhou) Co., Ltd.
- Publication Date: 2019-10-31
- Drug Name: Lamivudine tablets
- Inspection Finding: counterfeit drugs
- Summary: The Hubei Provincial Food and Drug Administration issued its Fourth Quarter 2012 "Hubei Provincial Drug Quality Bulletin" on February 27, 2013, following extensive drug quality supervision and sampling inspections. These inspections, conducted in Q4 2012 under the "Drug Administration Law of the People's Republic of China," covered 93 manufacturers, 1371 distribution enterprises, and 751 medical institutions across the province. A total of 5808 drug batches were sampled, with 376 batches (198 varieties) failing to meet quality standards.

Key violations included quality deficiencies in essential medicines, such as issues with related substances, particle size, and raw material control, often originating from manufacturers outside the province. Routine inspections identified counterfeit drugs, including imitations of Gliclazide Tablets and Lamivudine Tablets, and revealed problems with drug storage conditions affecting products like chloramphenicol eye drops. Special inspections highlighted significant concerns with traditional Chinese medicinal materials, involving illegal dyeing, adulteration, and substandard quality in numerous varieties, alongside deficiencies in pharmaceutical packaging materials related to raw materials and production processes.

In response, the administration mandates stringent actions: local authorities must enhance supervision, thoroughly investigate and prosecute non-compliant units, and refer suspected criminal offenses to public security. Specific directives include verifying transportation and storage conditions, increasing oversight of drug storage in distribution, and strengthening quality control for raw materials, particularly for traditional Chinese medicines. The bulletin underscores the ongoing need to vigorously investigate and penalize the presence of counterfeit drugs in the market.

Company: https://www.globalkeysolutions.net/companies/glaxosmithkline-pharmaceuticals-suzhou-co-ltd/8455d660-7408-48bf-87cd-d9fe1738655a/