Drug factory · FDA FEI 3003113148

Patheon Puerto Rico, Inc.

State Road #670 Km. 2.7, Manati, 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.

Jul 12, 2022 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.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.

Oct 15, 2019 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 any unexplained discrepancy whether or not the batch has been already distributed.

May 31, 2018 inspection

• Unlabeled filled containers controls 21 CFR 211.130(b)
  Filled drug product containers which are set aside and held in an unlabeled condition are not handled to preclude mislabeling of individual containers, lots or portions of lots.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.

Aug 11, 2014 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug product containers conform to appropriate standards of identity, strength, quality and purity.
• 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 and identity and strength of each active ingredient prior to release.
• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration, inspection, and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.

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