Altaire Pharmaceuticals Inc.
Form 483 issued April 19, 2019 · Aquebogue, New York
- Inspection
- Mar 25 – Apr 19, 2019
- Investigators
- Avital A. Shimanovich· Bijoy Panicker
- Observations
- 21
- Pages
- 32
- FEI number
- 1000119582
In short: On April 19, 2019, FDA issued a Form 483 with 21 observations to Altaire Pharmaceuticals Inc. in Aquebogue, New York (FEI 1000119582) after an inspection that ran Mar 25 – Apr 19, 2019. The investigators were Avital A. Shimanovich and Bijoy Panicker. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 15 of 21 observations.
Most cited: 21 CFR 211.42 (4×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Employees engaged in the manufacture of a drug product lack the training required to…
- 03
The control systems necessary to prevent contamination…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Avital A. Shimanovich
1 document · 2019
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 21 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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.?
Avital A. Shimanovich and Bijoy Panicker are named on this Form 483, for the inspection of Mar 25 – Apr 19, 2019. Each investigator has a profile showing what they cite most.
When was Altaire Pharmaceuticals Inc. inspected by FDA?
The inspection ran Mar 25 – Apr 19, 2019, and the Form 483 is dated April 19, 2019.
How do I get the full Form 483 for Altaire Pharmaceuticals Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.