FDA 483 - Garonit Pharmaceutical, Inc. - July 06, 2023

Garon Pharmaceutical Inc., an API manufacturer in Fairfield, NJ, was cited with two observations during an FDA inspection. The firm failed to extend investigations to other potentially affected batches following a contamination complaint and demonstrated deficiencies in documenting and investigating deviations. These issues indicate weaknesses in the firm's quality system regarding complaint handling and deviation management.