Gemini Pharmaceuticals, Inc. dba Plus Pharma
FDA inspection history in Commack, New York, 2011 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2015: one Form 483; 2018: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Commack, New York.
- 2015One Form 483, at Commack, New York.
- 2018One Form 483, at Commack, New York.
- 2018The longest 483 on file: 4 observations over 5 pages at Commack, New York.
- 2022One Form 483, at Commack, New York.
Cited most
Across all Gemini Pharmaceuticals, Inc. dba Plus Pharma observations on file
- 21 CFR 111.75(c)What must you do to determine whether specifications are met?1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.122(a)Materials examination and usage criteria1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(a)(2)Stability testing1
The complete Gemini Pharmaceuticals, Inc. dba Plus Pharma file.
All 4 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
Commack, New York
Four Form 483s · 2011 to 2022 · 11 observations
Latest: Form 483, Jul 26, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-26 | 483 Form 483 | Commack, New York | 1 | $99 |
| 2018-02-16 | 483 Form 483 | Commack, New York | 4 | $99 |
| 2015-06-30 | 483 Form 483 | Commack, New York | 4 | $99 |
| 2011-06-01 | 483 Form 483 | Commack, New York | 2 | $99 |
Investigators on these documents
Christopher S. Fields (2)Alice S. Tsao (1)Charisse K. Green (1)Deborah J. Parris (1)Jose O. Hernandez (1)
FEI number 2432926 · most recent document Jul 26, 2022
About Gemini Pharmaceuticals, Inc. dba Plus Pharma
How many FDA Form 483s has Gemini Pharmaceuticals, Inc. dba Plus Pharma received?
FDA Intel has 4 Form 483s on file for Gemini Pharmaceuticals, Inc. dba Plus Pharma; the most recent is dated Jul 26, 2022.
When was Gemini Pharmaceuticals, Inc. dba Plus Pharma last inspected by FDA?
The most recent FDA inspection document on file for Gemini Pharmaceuticals, Inc. dba Plus Pharma is a Form 483 dated Jul 26, 2022, for the site in Commack, New York.
What did FDA cite at Gemini Pharmaceuticals, Inc. dba Plus Pharma?
The regulations cited most in the observations on file for Gemini Pharmaceuticals, Inc. dba Plus Pharma are 21 CFR 111.75(c) (What must you do to determine whether specifications are met?), 1 time; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.122(a) (Materials examination and usage criteria), 1 time.