Chartwell Pharmaceuticals Congers, LLC
FDA inspection history in Congers, New York, 2018 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Congers, New York.
- 2023–24Two Form 483s, at Congers, New York.
- 2023The longest 483 on file: 6 observations over 5 pages at Congers, New York.
Cited most
Across all Chartwell Pharmaceuticals Congers observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.63Equipment design, size, and location2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
The complete Chartwell Pharmaceuticals Congers 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
Congers, New York
Three Form 483s · 2018 to 2024 · 15 observations
Latest: Form 483, Dec 19, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-19 | 483 Form 483 | Congers, New York | 5 | $99 |
| 2023-05-24 | 483 Form 483 | Congers, New York | 6 | $99 |
| 2018-09-26 | 483 Form 483 | Congers, New York | 4 | $99 |
Investigators on these documents
Alisha B. Patel (1)Ankur C. Patel (1)Josh Renzo N. Ramilo (1)Robin P. Mathew (1)Sony Mathews (1)
FEI number 3008897678 · most recent document Dec 19, 2024
About Chartwell Pharmaceuticals Congers, LLC
How many FDA Form 483s has Chartwell Pharmaceuticals Congers, LLC received?
FDA Intel has 3 Form 483s on file for Chartwell Pharmaceuticals Congers, LLC; the most recent is dated Dec 19, 2024.
When was Chartwell Pharmaceuticals Congers, LLC last inspected by FDA?
The most recent FDA inspection document on file for Chartwell Pharmaceuticals Congers, LLC is a Form 483 dated Dec 19, 2024, for the site in Congers, New York.
What did FDA cite at Chartwell Pharmaceuticals Congers, LLC?
The regulations cited most in the observations on file for Chartwell Pharmaceuticals Congers, LLC are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.63 (Equipment design, size, and location), 2 times.