Hospira Healthcare India, a Pfizer subsidiary, has received a warning letter from the FDA. The letter was the result of an inspection that identified serious GMP violations to corresponding Chapters of 21 CFR Part 211.
In the statement made in March, the FDA stated three reasons for the warning:
- "Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards."
- “Your firm failed 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."
- “Your firm failed 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."
During the inspection, one of the main problems identified was the tracing of data from personnel/environmental monitoring media plates, and Hospira staff confirmed that lab records did not accurately reflect the actual microbial growth observed on plates.
These findings mean that the FDA no longer has faith in the validity of the QC at the plant, and expects major changes in response to this warning. Although the FDA has weighed in, this is by no means an exhaustive list of issues. The organisation expects the company to look into the issues fully itself.
The letter also acknowledged that Hospira has brought in third-party consultants to continue performing product quality assessments, including ongoing review of adverse events and customer complaints about drugs remaining in distribution from the facility.
This comes just after the Indian pharma company voluntarily recalled products that potentially contained glass and copper salts. The fact that the company has brought in consultants to deal with the issues, seems appropriate and a good step towards fixing these ongoing issues.
The warning letter is available online.
N.B.This news story is based on the article published by ECA on its website www.gmp-compliance.org.