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# CGMP Violations at China’s Bingbing Pharmaceutical
- URL: https://www.fdaweb.com/cgmp-violations-at-chinas-bingbing-pharmaceutical/
- Published: 2019-11-05T12:00:00.000Z
- Updated: 2026-09-14T15:51:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145417

An FDA 5/7-5/10 inspection at Bingbing Pharmaceutical Co., Hubei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a just-released 10/3 [Warning Letter](ttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bingbing-pharmaceutical-co-ltd-584327-10032019). Specific violations were:

- failing to maintain written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the batch expiration date;
- failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
- failing to maintain an adequate written record of each complaint.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drug manufactured. FDA strongly recommends that Bingbing retain a qualified consultant to assist it in remediation. The company was told to submit **(1)** a comprehensive investigation into the extent of inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and **(3)** a management strategy for the company that includes details of its global corrective and preventive action plan.

FDA placed Bingbing on an 8/22 import alert. The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the steps.