Drug factory · FDA FEI 3004132058

Ohm Laboratories Inc.

14 Terminal Road, New Brunswick, NJ, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Feb 5, 2020 inspection

• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures and laboratory control mechanisms are not documented at the time of performance.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures and laboratory control mechanisms are not documented at the time of performance.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.

Dec 18, 2012 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not documented at the time of performance.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not documented at the time of performance.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.

Registered with FDA for: analysis; manufacture; pack; repack.