Altaire Pharmaceuticals Inc.
Form 483 issued April 13, 2015 · Aquebogue, New York
- Inspection
- Mar 31 – Apr 13, 2015
- Investigator
- Robert C. Horan
- Observations
- 8
- Pages
- 4
- FEI number
- 1000119582
In short: On April 13, 2015, FDA issued a Form 483 with 8 observations to Altaire Pharmaceuticals Inc. in Aquebogue, New York (FEI 1000119582) after an inspection that ran Mar 31 – Apr 13, 2015. The investigator was Robert C. Horan. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 6 of 8 observations.
Most cited: 21 CFR 211.160 (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
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Robert C. Horan
13 documents · 1998–2018
Cites 211.192 (production record review) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Altaire Pharmaceuticals Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Altaire Pharmaceuticals Inc.?
Robert C. Horan is named on this Form 483, for the inspection of Mar 31 – Apr 13, 2015. Each investigator has a profile showing what they cite most.
When was Altaire Pharmaceuticals Inc. inspected by FDA?
The inspection ran Mar 31 – Apr 13, 2015, and the Form 483 is dated April 13, 2015.
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.