Pillar5 Pharma Inc.
Form 483 issued February 7, 2025 · Arnprior, Canada
- Inspection
- Jan 30 – Feb 7, 2025
- Investigators
- Miguel A. Martinez· Patty P. Kaewussdangkul
- Observations
- 9
- Pages
- 18
- FEI number
- 3000241849
In short: On February 7, 2025, FDA issued a Form 483 with 9 observations to Pillar5 Pharma Inc. in Arnprior, Ontario (FEI 3000241849) after an inspection that ran Jan 30 – Feb 7, 2025. The investigators were Miguel A. Martinez and Patty P. Kaewussdangkul. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 7 of 9 observations.
Most cited: 21 CFR 211.192 (2×) · 211.170(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Written records of investigations into unexplained discrepancies do not include…
This inspection in context
Miguel A. Martinez
16 documents · 2014–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmPillar5 Pharma Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pillar5 Pharma Inc.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Pillar5 Pharma Inc.?
Miguel A. Martinez and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of Jan 30 – Feb 7, 2025. Each investigator has a profile showing what they cite most.
When was Pillar5 Pharma Inc. inspected by FDA?
The inspection ran Jan 30 – Feb 7, 2025, and the Form 483 is dated February 7, 2025.
How do I get the full Form 483 for Pillar5 Pharma Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.