Pillar5 Pharma Inc.
Form 483 issued December 15, 2023 · Arnprior, Canada
- Inspection
- Dec 7 – Dec 15, 2023
- Investigator
- Saundrea A. Munroe
- Observations
- 3
- Pages
- 6
- FEI number
- 3000241849
In short: On December 15, 2023, FDA issued a Form 483 with 3 observations to Pillar5 Pharma Inc. in Arnprior, Ontario (FEI 3000241849) after an inspection that ran Dec 7 – Dec 15, 2023. The investigator was Saundrea A. Munroe. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
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
Written records are not always made of…
- 03
Establishment of the reliability of the container and closure supplier's report of analyses is deficient in…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pillar5 Pharma Inc.?
FDA listed 3 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Pillar5 Pharma Inc.?
Saundrea A. Munroe is named on this Form 483, for the inspection of Dec 7 – Dec 15, 2023. Each investigator has a profile showing what they cite most.
When was Pillar5 Pharma Inc. inspected by FDA?
The inspection ran Dec 7 – Dec 15, 2023, and the Form 483 is dated December 15, 2023.
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.