# China NMPA Drug Inspection - Shanghai Huayuan Anhui Renji Pharmaceutical Co., Ltd. - Norfloxacin capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanghai-huayuan-anhui-renji-pharmaceutical-co-ltd/4adadbe9-b458-439c-bbd3-13e80fc3e689/
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> China NMPA drug inspection for Shanghai Huayuan Anhui Renji Pharmaceutical Co., Ltd. published April 28, 2017. Drug: Norfloxacin capsules. The Hubei Provincial Food and Drug Administration issued an announcement on April 28, 2017, detailing drug quality sampl

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Hubei Province Drug Quality Bulletin (Issue 1, 2017)
- Company Name: Shanghai Huayuan Anhui Renji Pharmaceutical Co., Ltd.
- Publication Date: 2017-04-28
- Drug Name: Norfloxacin capsules
- Inspection Finding: Check (dissolution rate)
- Action Taken: In accordance with the provisions of the "Drug Administration Law of the People's Republic of China", this matter shall be investigated and dealt with, and the results and relevant circumstances shall be reported to the Provincial Bureau in a timely manner.
- Summary: The Hubei Provincial Food and Drug Administration issued an announcement on April 28, 2017, detailing drug quality sampling inspections conducted during the first quarter of 2017. These inspections covered drug production, operation, and use units across Hubei province, identifying 28 batches of drugs that failed to meet quality standards. Manufacturers involved included Tianma (Anhui) TCM Decoction Pieces Technology Co., Ltd. and Jilin Jingxin Pharmaceutical Group Co., Ltd., among many others, with issues found at various pharmacies and health centers. The primary violations spanned both Traditional Chinese Medicine (TCM) decoction pieces and prepared medicines. Non-compliant TCM items frequently showed issues with total ash content, moisture levels, sulfur dioxide residue, or failed identification tests, indicating potential adulteration or improper processing. Prepared medicines, such as Musk Bone-Setting Capsules and Norfloxacin Capsules, exhibited problems including content weight variation, microbial limits, and dissolution failures. These findings were evaluated against the "Drug Administration Law of the People's Republic of China," along with relevant editions of the Chinese Pharmacopoeia and specific Ministry of Health Drug Standards. As a result, local food and drug administration departments were mandated to thoroughly investigate the non-compliant drugs and associated units. Required actions include enforcing penalties, reporting findings to the Provincial Bureau, and diligently tracing the source of any drugs from unverified manufacturers. Cases involving suspected criminal activity, such as counterfeit products, are to be transferred to public security authorities for prosecution. This initiative underscores Hubei province's commitment to ensuring drug quality and safety.

Company: https://www.globalkeysolutions.net/companies/shanghai-huayuan-anhui-renji-pharmaceutical-co-ltd/5218d0da-8867-4f39-b98b-bd5186d1dc16/