Apot ex Inc.
Form 483 issued May 9, 2025 · Richmond Hill, Canada
- Inspection
- Apr 28 – May 9, 2025
- Investigators
- Justin A. Boyd· Wayne D. McGrath
- Observations
- 10
- Pages
- 24
- FEI number
- 3001617666
In short: On May 9, 2025, FDA issued a Form 483 with 10 observations to Apot ex Inc. in Richmond Hill, Canada (FEI 3001617666) after an inspection that ran Apr 28 – May 9, 2025. The investigators were Justin A. Boyd and Wayne D. McGrath. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmApot ex Inc. history
All 4 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 Apot ex Inc.?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Apot ex Inc.?
Justin A. Boyd and Wayne D. McGrath are named on this Form 483, for the inspection of Apr 28 – May 9, 2025. Each investigator has a profile showing what they cite most.
When was Apot ex Inc. inspected by FDA?
The inspection ran Apr 28 – May 9, 2025, and the Form 483 is dated May 9, 2025.
How do I get the full Form 483 for Apot ex 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.