GMP Violations Bring 483 for Strem Chemicals

April 17, 2015

FDA investigators identified a slew of GMP deviations at Strem Chemicals’ Newburyport, Mass., facility, resulting in a Form 483.

During five days of inspections between April 8 and April 18, 2014, investigators found that the drugmaker failed to establish inventory controls for its active pharmaceutical ingredients. Specifically, Strem’s business and quality inventory tracking records are inadequate because data isn’t consistently captured for storage of APIs.

Strem also failed to establish adequate batch release procedures for APIs slated for partial shipments to suppliers. The procedures the firm has don’t include a quality assessment, and the release process is limited to a review of the products’ labeling and certificate of analysis, investigators say.

Further, the company doesn’t follow proper cleanroom procedures to protect products from contamination. Although Strem has a specific gowning policy, two chemists were observed entering the GMP suite without following that policy, the form says.

Finally, Strem failed to establish and maintain proper CAPA processes, including quality records and service reports to identify existing and potential causes of nonconforming product or other quality problems, the form says.

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