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.
The FDA asked Milbar to conduct complete investigations into all contaminated lots, including the likely cause, a comprehensive assessment of manufacturing operations and a detailed CAPA plan and risk assessment.
The agency also cited the company for failing to:
- Nix components that didn’t meet the written specifications for identity, strength, quality and purity;
- Adequately address the potential risk posed by contamination in its water system;
- Properly address consumer complaints, simply issuing a credit to a customer who complained about a product “running out like oil” instead of performing an investigation;
- Thoroughly investigate complaints of products burning the skin;
- Provide evidence that it fully investigated OOS results and complaints;
- Validate processes for its OTC drug; and
- Continuously monitor process controls.