Altaire Pharmaceuticals Inc.
Form 483 issued February 11, 2022 · Aquebogue, New York
- Inspection
- Feb 11, 2022
- Investigators
- Bijoy Panicker· Jazmine N. Still· Juanita P. Versace
- Observations
- 17
- Pages
- 19
- FEI number
- 1000119582
In short: On February 11, 2022, FDA issued a Form 483 with 17 observations to Altaire Pharmaceuticals Inc. in Aquebogue, New York (FEI 1000119582) after an inspection that ran Feb 11, 2022. The investigators were Bijoy Panicker, Jazmine N. Still and Juanita P. Versace. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (4×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAltaire Pharmaceuticals Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Altaire Pharmaceuticals Inc.?
FDA listed 17 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Altaire Pharmaceuticals Inc.?
Bijoy Panicker, Jazmine N. Still and Juanita P. Versace are named on this Form 483, for the inspection of Feb 11, 2022. Each investigator has a profile showing what they cite most.
When was Altaire Pharmaceuticals Inc. inspected by FDA?
The inspection ran Feb 11, 2022, and the Form 483 is dated February 11, 2022.
How do I get the full Form 483 for Altaire Pharmaceuticals Inc.?
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