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Pharmaceuticals / Submissions and Approvals

FDA Warns Florida Contract Manufacturer for Cleaning, Testing Issues

March 12, 2019
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Fort Lauderdale contract drug manufacturer ANDAPharm drew a warning letter from the FDA for repeat cleaning deficiencies, inadequate stability protocols and other serious problems.

In a July 10-18, 2018 inspection, the agency found the facility had extended hold times for dirty equipment — such as an encapsulator used to produce microbeads and microcapsules — that were not supported by validation data. The facility also lacked timeframes for replacing components and cleaning tablet coating equipment.

The firm also lacked an adequate stability testing program — a repeat violation from previous inspections in 2012 and 2016. Stability protocols for multiple lots of salsalate, phenazopyridine and hyoscyamine sulfate products were missing information on tests, storage conditions and study lengths.

The FDA inspectors found rejected lots of phenazopyridine, salsalate and chloradiazepoxide/clindium bromide in the firm’s receiving area, but they were not recorded in the reject log book and were not labeled as rejected. The FDA warned the firm of the need to maintain adequate control over material flow and segregation “to avoid potential mix-ups and release of rejected lots.”

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