Drugs

CGMP Violations at Hospira Healthcare India

A 3/27-4/3/18 FDA inspection at Pfizer’s Hospira Healthcare India drug manufacturing facility in Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/4 Warning Letter says the specific violations were:

failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards;
failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
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.

The letter says the site’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA acknowledges that Hospira is using a consultant to audit its operation and help it meet agency requirements and asks for (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of observed failures on the quality of the company’s drugs; and (3) a management strategy for the company including details of its global corrective and preventive action plan.

The letter acknowledges the company’s decision to cease all production and distribution of drug products from the site due to significant long-term loss of product demand. It also acknowledges the company’s commitment for third-party consultants to continue performing product quality assessments, including ongoing review of adverse events and customer complaints for drugs remaining in distribution from the facility.

The firm was placed on import alert 8/1/18.

Hospira was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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