Apot ex Inc.
Form 483 issued September 14, 2022 · Richmond Hill, Canada
- Inspection
- Sep 6 – Sep 14, 2022
- Investigator
- Camerson E. Moore
- Observations
- 1
- Pages
- 1
- FEI number
- 3001617666
In short: On September 14, 2022, FDA issued a Form 483 with 1 observation to Apot ex Inc. in Richmond Hill, Ontario (FEI 3001617666) after an inspection that ran Sep 6 – Sep 14, 2022. The investigator was Camerson E. Moore. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 1 observation on this Form 483, mostly about production. 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.?
Camerson E. Moore is named on this Form 483, for the inspection of Sep 6 – Sep 14, 2022. Each investigator has a profile showing what they cite most.
When was Apot ex Inc. inspected by FDA?
The inspection ran Sep 6 – Sep 14, 2022, and the Form 483 is dated September 14, 2022.
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.