FDA 483 - Ohm Laboratories Inc. - February 05, 2020

Ohm Laboratories Inc. in New Brunswick, NJ, was cited for significant deficiencies during an FDA inspection, primarily concerning their Doxycycline products. The firm failed to conduct comprehensive investigations into out-of-trend and out-of-specification results, leading to incomplete assessments of incorrect reference standard use and overstated potency values. Additionally, the quality control unit did not adhere to procedures, notably by delaying the submission of Field Alert Reports, and laboratory control mechanisms showed numerous instances of altered sample sets in audit trails after testing.