Chemco Corp
FDA inspection history across 2 sites, 2017 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2017: one Form 483; 2022: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Miami Lakes, Florida.
- 2017The longest 483 on file: 6 observations over 6 pages at Miami Lakes, Florida.
- 2022One Form 483, at Hialeah, Florida.
- 2026One warning letter, at Miami Lakes, Florida.
Cited most
Across all Chemco observations on file
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.192Production record review2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.182Equipment cleaning and use log1
The complete Chemco file.
All 3 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
Miami Lakes, Florida
One warning letter and one Form 483 · 2017 to 2026 · 6 observations
Latest: Warning letter, Apr 7, 2026 →Hialeah, Florida
One Form 483 · 2022 · 5 observations
Latest: Form 483, Oct 31, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-07 | Warning letter Warning letter | Miami Lakes, Florida | — | $99 |
| 2022-10-31 | 483 Form 483 | Hialeah, Florida | 5 | $99 |
| 2017-03-06 | 483 Form 483 | Miami Lakes, Florida | 6 | $99 |
Investigators on these documents
Jennifer Lalama (2)Damaris Y. Hernandez (1)Rozelle G. Smith (1)
FEI number 1042599 · most recent document Apr 7, 2026
About Chemco Corp
How many FDA Form 483s has Chemco Corp received?
FDA Intel has 2 Form 483s on file for Chemco Corp; the most recent is dated Oct 31, 2022.
When was Chemco Corp last inspected by FDA?
The most recent FDA inspection document on file for Chemco Corp is a Form 483 dated Oct 31, 2022, for the site in Hialeah, Florida.
What did FDA cite at Chemco Corp?
The regulations cited most in the observations on file for Chemco Corp are 21 CFR 211.165 (Testing and release for distribution), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.
Has Chemco Corp received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Chemco Corp; the most recent is dated Apr 7, 2026.