ScieGen Pharmaceuticals, INC.
FDA inspection history in Hauppauge, New York, 2011 to 2023
- 5
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2015: one Form 483; 2021: one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Hauppauge, New York.
- 2015One Form 483, at Hauppauge, New York.
- 2021–23Three Form 483s, at Hauppauge, New York.
- 2022The longest 483 on file: 2 observations over 4 pages at Hauppauge, New York.
Cited most
Across all ScieGen Pharmaceuticals observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.160General requirements1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete ScieGen 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 · 2011 to 2023 · 7 observations
Latest: Form 483, Apr 21, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-21 | 483 Form 483 | Hauppauge, New York | 1 | $99 |
| 2022-09-02 | 483 Form 483 | Hauppauge, New York | 2 | $99 |
| 2021-12-20 | 483 Form 483 | Hauppauge, New York | 1 | $99 |
| 2015-01-09 | 483 Form 483 | Hauppauge, New York | 1 | $99 |
| 2011-09-16 | 483 Form 483 | Hauppauge, New York | 2 | $99 |
Investigators on these documents
Robert C. Horan (2)Gam S. Zamil (1)Neil J. Bonzagni (1)Sayyem H. Akbar (1)Vivin George (1)Xikui Chen (1)
FEI number 3008298016 · most recent document Apr 21, 2023
About ScieGen Pharmaceuticals, INC.
How many FDA Form 483s has ScieGen Pharmaceuticals, INC. received?
FDA Intel has 5 Form 483s on file for ScieGen Pharmaceuticals, INC.; the most recent is dated Apr 21, 2023.
When was ScieGen Pharmaceuticals, INC. last inspected by FDA?
The most recent FDA inspection document on file for ScieGen Pharmaceuticals, INC. is a Form 483 dated Apr 21, 2023, for the site in Hauppauge, New York.
What did FDA cite at ScieGen Pharmaceuticals, INC.?
The regulations cited most in the observations on file for ScieGen Pharmaceuticals, INC. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.142 (Warehousing procedures), 1 time; 21 CFR 211.160 (General requirements), 1 time.