Drug factory · FDA FEI 2623619

Viatris Pharmaceuticals LLC

Road 689 Km 1.9, Vega Baja, PR, 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.

May 18, 2026 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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.
• 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.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.

Feb 17, 2022 inspection

• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.

Jan 26, 2018 inspection

• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Jul 26, 2016 inspection

• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures are not followed.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine inspection and checking of electronic equipment is not performed according to a written program designed to assure proper performance.

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