Altaire Pharmaceuticals Inc.
FDA inspection history in Aquebogue, New York, 2011 to 2022
- 5
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2011: one warning letter; 2015: two Form 483s; 2017: one Form 483; 2019: one Form 483; 2020: one close-out letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Aquebogue, New York.
- 2015–22Five Form 483s and one close-out letter, at Aquebogue, New York.
- 2019The longest 483 on file: 21 observations over 32 pages at Aquebogue, New York.
Cited most
Across all Altaire Pharmaceuticals observations on file
- 21 CFR 211.42Design and construction features9
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.160General requirements8
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit4
The complete Altaire Pharmaceuticals file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Aquebogue, New York
Five Form 483s, one close-out letter and one warning letter · 2011 to 2022 · 56 observations
Latest: Form 483, Feb 11, 2022 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-11 | 483 Form 483 | Aquebogue, New York | 17 | $99 |
| 2020-03-12 | Close-out Close-out letter | Aquebogue, New York | — | $99 |
| 2019-04-19 | 483 Form 483 | Aquebogue, New York | 21 | $99 |
| 2017-03-09 | 483 Form 483 | Aquebogue, New York | 5 | $99 |
| 2015-12-15 | 483 Form 483 | Aquebogue, New York | 5 | $99 |
| 2015-04-13 | 483 Form 483 | Aquebogue, New York | 8 | $99 |
| 2011-11-16 | Warning letter Warning letter | Aquebogue, New York | — | $99 |
Investigators on these documents
Robert C. Horan (3)Bijoy Panicker (2)Avital A. Shimanovich (1)Jazmine N. Still (1)Juanita P. Versace (1)
FEI number 1000119582 · most recent document Feb 11, 2022
About Altaire Pharmaceuticals Inc.
How many FDA Form 483s has Altaire Pharmaceuticals Inc. received?
FDA Intel has 5 Form 483s on file for Altaire Pharmaceuticals Inc.; the most recent is dated Feb 11, 2022.
When was Altaire Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Altaire Pharmaceuticals Inc. is a Form 483 dated Feb 11, 2022, for the site in Aquebogue, New York.
What did FDA cite at Altaire Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Altaire Pharmaceuticals Inc. are 21 CFR 211.42 (Design and construction features), 9 times; 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.160 (General requirements), 8 times.
Has Altaire Pharmaceuticals Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Altaire Pharmaceuticals Inc.; the most recent is dated Nov 16, 2011.