Steri-Med Pharma Inc.
Form 483 issued February 27, 2024 · Upton, Canada
- Inspection
- Feb 19 – Feb 27, 2024
- Investigator
- Matthew B. Casale
- Observations
- 1
- Pages
- 2
- FEI number
- 3010165586
In short: On February 27, 2024, FDA issued a Form 483 with 1 observation to Steri-Med Pharma Inc. in Upton, Quebec (FEI 3010165586) after an inspection that ran Feb 19 – Feb 27, 2024. The investigator was Matthew B. Casale. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmSteri-Med Pharma Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Steri-Med Pharma Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Steri-Med Pharma Inc.?
Matthew B. Casale is named on this Form 483, for the inspection of Feb 19 – Feb 27, 2024. Each investigator has a profile showing what they cite most.
When was Steri-Med Pharma Inc. inspected by FDA?
The inspection ran Feb 19 – Feb 27, 2024, and the Form 483 is dated February 27, 2024.
How do I get the full Form 483 for Steri-Med 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.