India-based API maker Vital Laboratories was slapped with a warning letter from the FDA over manufacturing and records issues at its Plant II located in Vapi, Gujarat.
The facility was inspected between April 3-6 by the U.S. regulatory agency, which found numerous issues with the plant’s good manufacturing practice.
In a letter posted on the agency’s website, the FDA said its inspectors found Vital employees didn’t perform in-process assay tests for at least five batches of APIs in 2016 but had no explanation for the failure to conduct these tests.
Additionally, the company was cited for failing to “document the completion of each significant step in the batch production records with signatures of the persons performing and directly supervising or checking each critical step in the operation.” Vital also didn’t investigate and record out-of-specification results and take corrective actions. The plant’s quality unit was cited for not adequately performing annual product reviews, the FDA said.
The FDA made a point to Vital that it has had repeat deviations at some of its other plants, particularly its other production facility in Vapi that was inspected in 2015. The result of that inspection was that the facility, which was formerly known as Vital Healthcare Private Limited, was classified as unacceptable for drug manufacturing.
“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the FDA said.