FDA EIR - Ohm Laboratories Inc. - August 17, 2018

An FDA Pre-Approval Inspection of Ohm Laboratories Inc., a finished dosage manufacturer in New Brunswick, NJ, was conducted from August 13 to August 17, 2018. The inspection, carried out under current Good Manufacturing Practices (cGMP) regulations (Section 501(a)(2)(b) of the Food Drug and Cosmetic Act), resulted in an FDA Form 483 citing four significant deficiencies. Key violations included failures in Quality Control Unit responsibilities, specifically the delayed initiation of Out-of-Specification (OOS) investigations —one instance showed a six-month delay for a content uniformity OOS. There was also a lack of Quality Unit oversight in critical decisions, such as discontinuing an exhibit batch without documented approval, and several exhibit batch reports lacked Quality Unit review. A significant issue involved an 8-day humidity excursion in a stability chamber containing accelerated stability samples for an ANDA product, which was inadequately investigated with insufficient justification for extending stability study timelines. Other observations included incomplete investigation records lacking proper conclusions and follow-up, poorly maintained manufacturing equipment (e.g., a granulator with excessive scratches), and unrepresentative sampling methodologies. Ohm Laboratories' management acknowledged these findings and committed to submitting a written response to the agency within 15 business days.