InvaGen Pharmaceuticals, Inc.
FDA inspection history in Hauppauge, New York, 2015 to 2019
- 5
- Form 483s
Every document, by year
- Form 483
2015: two Form 483s; 2017: one Form 483; 2018: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Five Form 483s, at Hauppauge, New York.
- 2018The longest 483 on file: 6 observations over 6 pages at Hauppauge, New York.
Cited most
Across all InvaGen Pharmaceuticals observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 314.80Postmarketing reporting of adverse drug experiences2
- 21 CFR 314.81(b)(1)(i)Other postmarketing reports2
- 21 CFR 111
The complete InvaGen Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Hauppauge, New York
Five Form 483s · 2015 to 2019 · 15 observations
Latest: Form 483, Dec 6, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-06 | 483 Form 483 | Hauppauge, New York | 3 | $99 |
| 2018-05-25 | 483 Form 483 | Hauppauge, New York | 6 | $99 |
| 2017-03-30 | 483 Form 483 | Hauppauge, New York | — | $99 |
| 2015-05-26 | 483 Form 483 | Hauppauge, New York | 1 | $99 |
| 2015-03-13 | 483 Form 483 | Hauppauge, New York | 5 | $99 |
Investigators on these documents
Alice S. Tsao (1)Bijoy Panicker (1)Mindy M. Chou (1)Robert C. Horan (1)
FEI number 3003950641 · most recent document Dec 6, 2019
About InvaGen Pharmaceuticals, Inc.
How many FDA Form 483s has InvaGen Pharmaceuticals, Inc. received?
FDA Intel has 5 Form 483s on file for InvaGen Pharmaceuticals, Inc.; the most recent is dated Dec 6, 2019.
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 Dec 6, 2019, for the site in Hauppauge, 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 211.192 (Production record review), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 314.80 (Postmarketing reporting of adverse drug experiences), 2 times.