FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

New York OTC Drugmaker Scolded for Missing Lab Studies, GMP Training

June 13, 2019
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The FDA cited Advance Pharmaceutical in a Form 483 for problems with verification and training at its Holtsville, New York facility.

The agency’s Nov. 26-Dec. 13, 2018 inspection revealed that the firm failed to verify tests for  uniformity, dissolution and impurity for numerous products — including aspirin, acetaminophen, diphenhydramine and guaifenesin.

The facility also failed to conduct qualification studies for three high-performance liquid chromatography (HPLC) systems used in the analytical laboratory, the FDA investigator found. It also lacked qualification studies for capsule filling machines and tablet presses.

The FDA also rapped the OTC drug manufacturer for its electronic records. For example, an HPLC data acquisition software system had no controls to prevent users from deleting or altering raw data files.

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