Nomax, INC
FDA inspection history in Saint Louis, Missouri, 2016 to 2022
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2016: one warning letter; 2018: one close-out letter and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18One warning letter, one close-out letter and one Form 483, at Saint Louis, Missouri.
- 2022One Form 483, at Saint Louis, Missouri.
- 2022The longest 483 on file: 3 observations over 5 pages at Saint Louis, Missouri.
Cited most
Across all Nomax observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.170Reserve samples1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Nomax 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
Saint Louis, Missouri
Two Form 483s, one close-out letter and one warning letter · 2016 to 2022 · 5 observations
Latest: Form 483, Dec 2, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-02 | 483 Form 483 | Saint Louis, Missouri | 3 | $99 |
| 2018-08-21 | Close-out Close-out letter | Saint Louis, Missouri | — | $99 |
| 2018-02-01 | 483 Form 483 | Saint Louis, Missouri | 2 | $99 |
| 2016-12-15 | Warning letter Warning letter | Saint Louis, Missouri | — | $99 |
Investigators on these documents
FEI number 1937310 · most recent document Dec 2, 2022
About Nomax, INC
How many FDA Form 483s has Nomax, INC received?
FDA Intel has 2 Form 483s on file for Nomax, INC; the most recent is dated Dec 2, 2022.
When was Nomax, INC last inspected by FDA?
The most recent FDA inspection document on file for Nomax, INC is a Form 483 dated Dec 2, 2022, for the site in Saint Louis, Missouri.
What did FDA cite at Nomax, INC?
The regulations cited most in the observations on file for Nomax, INC are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.170 (Reserve samples), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Nomax, INC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Nomax, INC; the most recent is dated Dec 15, 2016.