Drug factory · FDA FEI 3000241849

Pillar5 Pharma Inc

365 Madawaska Blvd., Arnprior, Canada

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.

Jun 5, 2026 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• 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.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.

Feb 7, 2025 inspection

• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
• 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 conform to appropriate standards of identity, strength, quality and purity.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Drug product reserve containers 21 CFR 211.170(b)
  Drug product reserve samples are not stored in an immediate container-closure system that has essentially the same characteristics as the marketed product.
• 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.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
• Laboratory equipment calibration records 21 CFR 211.194(d)
  Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Dec 15, 2023 inspection

• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(3)
  Establishment of the reliability of the container and closure supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Feb 21, 2020 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

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