InvaGen Pharmaceuticals, Inc.
FDA inspection history in Central Islip, New York, 2018 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Central Islip, New York.
- 2023One Form 483, at Central Islip, New York.
- 2023The longest 483 on file: 5 observations over 5 pages at Central Islip, New York.
Cited most
Across all InvaGen Pharmaceuticals observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete InvaGen Pharmaceuticals 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
Central Islip, New York
Two Form 483s · 2018 to 2023 · 8 observations
Latest: Form 483, Sep 19, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-19 | 483 Form 483 | Central Islip, New York | 5 | $99 |
| 2018-12-19 | 483 Form 483 | Central Islip, New York | 3 | $99 |
Investigators on these documents
FEI number 3012696190 · most recent document Sep 19, 2023
About InvaGen Pharmaceuticals, Inc.
How many FDA Form 483s has InvaGen Pharmaceuticals, Inc. received?
FDA Intel has 2 Form 483s on file for InvaGen Pharmaceuticals, Inc.; the most recent is dated Sep 19, 2023.
When was InvaGen Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for InvaGen Pharmaceuticals, Inc. is a Form 483 dated Sep 19, 2023, for the site in Central Islip, New York.
What did FDA cite at InvaGen Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for InvaGen Pharmaceuticals, Inc. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time.