Apot ex Inc.
FDA inspection history in Richmond Hill, Canada, 2014 to 2025
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2014: one close-out letter; 2022: one Form 483; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One close-out letter.
- 2022One Form 483, at Richmond Hill, Canada.
- 2025One warning letter and one Form 483, at Richmond Hill, Canada.
- 2025The longest 483 on file: 10 observations over 24 pages at Richmond Hill, Canada.
Cited most
Across all Apot ex observations on file
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.192Production record review1
The complete Apot ex file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Richmond Hill, Canada
Two Form 483s · 2022 to 2025 · 11 observations
Latest: Form 483, May 9, 2025 →
Also: two documents not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-10-31 | Warning letter Warning letter | — | — | $99 |
| 2025-05-09 | 483 Form 483 | Richmond Hill, Canada | 10 | $99 |
| 2022-09-14 | 483 Form 483 | Richmond Hill, Canada | 1 | $99 |
| 2014-05-02 | Close-out Close-out letter | — | — | $99 |
Investigators on these documents
FEI number 3001617666 · most recent document Oct 31, 2025
About Apot ex Inc.
How many FDA Form 483s has Apot ex Inc. received?
FDA Intel has 2 Form 483s on file for Apot ex Inc.; the most recent is dated May 9, 2025.
When was Apot ex Inc. last inspected by FDA?
The most recent FDA inspection document on file for Apot ex Inc. is a Form 483 dated May 9, 2025, for the site in Richmond Hill, Canada.
What did FDA cite at Apot ex Inc.?
The regulations cited most in the observations on file for Apot ex Inc. are 21 CFR 211.113(b) (Control of microbiological contamination), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time.
Has Apot ex Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Apot ex Inc.; the most recent is dated Oct 31, 2025.