FDA Hits California Drugmaker for Audits, Batch Records

October 31, 2018

The FDA cited an API manufacturing facility in Torrance, California, for deficiencies in quality assurance, preventive maintenance, audits and batch records.

During a May inspection of the Bachem Americas facility, the agency found the company failed to review and approve quality system investigations in a timely manner and noted delayed dates for final QA signatures for four of eight reviewed deviations.

The FDA also found the company did not follow its written procedures for product reviews or perform timely preventive maintenance.

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