# China NMPA Inspection - Tianjin Children's Pharmaceutical Co., Ltd. - February 23, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-childrens-pharmaceutical-co-ltd/f7304b44-230f-4119-8f54-a0606e2f4c5e/
Source feed: China

> China NMPA unannounced inspection for Tianjin Children's Pharmaceutical Co., Ltd. published February 23, 2017. An unannounced inspection of Tianjin Children's Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and the Tianjin Munic

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Tianjin Children's Pharmaceutical Co., Ltd.
- Company Name: Tianjin Children's Pharmaceutical Co., Ltd.
- Publication Date: 2017-02-23
- Product Type: Drugs
- Summary: An unannounced inspection of Tianjin Children's Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and the Tianjin Municipal Market and Quality Supervision and Management Commission from December 9-11, 2016. The inspection revealed significant quality control and compliance deficiencies.

Primary concerns centered on cefaclor granules, where market inspections identified multiple substandard batches regarding content, acidity, and dissolution. The company's investigations into these issues were either inadequate or records were unavailable. Furthermore, stability study results for a cefaclor batch showed content below acceptable limits, prompting a delayed decision to recall, without proper initial investigation.

Material sourcing and quality control practices were also found wanting. The company's internal quality standards for cefaclor impurities did not align with the Chinese Pharmacopoeia. Raw material sampling procedures were not followed, and a critical raw material supplier (Lupin Limited) was not audited according to Good Manufacturing Practice (GMP) requirements, despite ongoing quality issues.

Additional violations included inadequate cleaning of production equipment, leading to residual powder and contamination risks, and unapproved changes to production parameters (feed loss and amount adjustment for cefaclor granules) without proper change control.

These actions violated the "Drug Administration Law of the People's Republic of China" and associated GMP regulations. Consequently, regulatory authorities mandated the revocation of the company's GMP certificates, supervision of product recalls, and initiation of an investigation into the company's non-compliant activities.

Company: https://www.globalkeysolutions.net/companies/tianjin-childrens-pharmaceutical-co-ltd/8ea0bc46-ebe1-49e2-9291-e0d2ea4b016c/