Max Chemical, Inc.
FDA inspection history in Rio Piedras, Puerto Rico, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Rio Piedras, Puerto Rico.
Cited most
Across all Max Chemical observations on file
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.63Equipment design, size, and location1
The complete Max Chemical file.
All 2 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
Rio Piedras, Puerto Rico
One Form 483 · 2024 · 6 observations
Latest: Form 483, Mar 15, 2024 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-20 | Warning letter Warning letter | — | — | $99 |
| 2024-03-15 | 483 Form 483 | Rio Piedras, Puerto Rico | 6 | $99 |
Investigators on these documents
FEI number 3002088200 · most recent document Jun 20, 2024
About Max Chemical, Inc.
How many FDA Form 483s has Max Chemical, Inc. received?
FDA Intel has 1 Form 483 on file for Max Chemical, Inc.; the most recent is dated Mar 15, 2024.
When was Max Chemical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Max Chemical, Inc. is a Form 483 dated Mar 15, 2024, for the site in Rio Piedras, Puerto Rico.
What did FDA cite at Max Chemical, Inc.?
The regulations cited most in the observations on file for Max Chemical, Inc. are 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Max Chemical, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Max Chemical, Inc.; the most recent is dated Jun 20, 2024.