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Pharmaceuticals / Inspections and Audits

Milbar Laboratories Warned for Contaminated Product

Aug. 8, 2018

The FDA sent a warning letter to Connecticut-based drugmaker Milbar Laboratories for quality deficiencies and failure to investigate out-of-specification batches.

A December 2017 inspection of the company’s East Haven facility found the company distributed over-the-counter topical drug product lots with significant levels of microbial contamination.

In January, the company told the agency it had implemented more in-depth batch review procedures and would address any outstanding out-of-specifications with appropriate corrective actions. But the FDA said the company failed to explain why it distributed the contaminated lots in the first place or to address the need for overall improvements in its quality system.

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