Ascent Pharmaceuticals Inc
FDA inspection history in Central Islip, New York, 2020 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–24Three Form 483s, at Central Islip, New York.
- 2020The longest 483 on file: 4 observations over 6 pages at Central Islip, New York.
Cited most
Across all Ascent Pharmaceuticals observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.80General requirements1
The complete Ascent Pharmaceuticals 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
Central Islip, New York
Three Form 483s · 2020 to 2024 · 9 observations
Latest: Form 483, Aug 9, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-09 | 483 Form 483 | Central Islip, New York | 4 | $99 |
| 2022-09-15 | 483 Form 483 | Central Islip, New York | 1 | $99 |
| 2020-10-13 | 483 Form 483 | Central Islip, New York | 4 | $99 |
Investigators on these documents
FEI number 3009518416 · most recent document Aug 9, 2024
About Ascent Pharmaceuticals Inc
How many FDA Form 483s has Ascent Pharmaceuticals Inc received?
FDA Intel has 3 Form 483s on file for Ascent Pharmaceuticals Inc; the most recent is dated Aug 9, 2024.
When was Ascent Pharmaceuticals Inc last inspected by FDA?
The most recent FDA inspection document on file for Ascent Pharmaceuticals Inc is a Form 483 dated Aug 9, 2024, for the site in Central Islip, New York.
What did FDA cite at Ascent Pharmaceuticals Inc?
The regulations cited most in the observations on file for Ascent Pharmaceuticals Inc are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.