Chartwell Pharmaceuticals Carmel, LLC
FDA inspection history in Carmel, New York, 2018 to 2024
- 5
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2022: one Form 483; 2024: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Carmel, New York.
- 2022–24Three Form 483s, at Carmel, New York.
- 2022The longest 483 on file: 6 observations over 6 pages at Carmel, New York.
Cited most
Across all Chartwell Pharmaceuticals Carmel observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.63Equipment design, size, and location2
- 21 CFR 211.103Calculation of yield1
The complete Chartwell Pharmaceuticals Carmel file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Carmel, New York
Five Form 483s · 2018 to 2024 · 17 observations
Latest: Form 483, Dec 20, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-20 | 483 Form 483 | Carmel, New York | 3 | $99 |
| 2024-01-11 | 483 Form 483 | Carmel, New York | 3 | $99 |
| 2022-10-06 | 483 Form 483 | Carmel, New York | 6 | $99 |
| 2019-12-16 | 483 Form 483 | Carmel, New York | 3 | $99 |
| 2018-02-28 | 483 Form 483 | Carmel, New York | 2 | $99 |
Investigators on these documents
Andrew O. Ejiofor (1)Bijoy Panicker (1)Brandy N. Lepage (1)Helen B. Ricalde (1)Mindy M. Chou (1)
FEI number 3009686761 · most recent document Dec 20, 2024
About Chartwell Pharmaceuticals Carmel, LLC
How many FDA Form 483s has Chartwell Pharmaceuticals Carmel, LLC received?
FDA Intel has 5 Form 483s on file for Chartwell Pharmaceuticals Carmel, LLC; the most recent is dated Dec 20, 2024.
When was Chartwell Pharmaceuticals Carmel, LLC last inspected by FDA?
The most recent FDA inspection document on file for Chartwell Pharmaceuticals Carmel, LLC is a Form 483 dated Dec 20, 2024, for the site in Carmel, New York.
What did FDA cite at Chartwell Pharmaceuticals Carmel, LLC?
The regulations cited most in the observations on file for Chartwell Pharmaceuticals Carmel, LLC are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.