Altaire Pharmaceuticals Inc.
Form 483 issued March 9, 2017 · Aquebogue, New York
- Inspection
- Feb 27 – Mar 9, 2017
- Investigator
- Robert C. Horan
- Observations
- 5
- Pages
- 5
- FEI number
- 1000119582
In short: On March 9, 2017, FDA issued a Form 483 with 5 observations to Altaire Pharmaceuticals Inc. in Aquebogue, New York (FEI 1000119582) after an inspection that ran Feb 27 – Mar 9, 2017. The investigator was Robert C. Horan. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Altaire Pharmaceuticals Inc.?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and quality system. 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 Feb 27 – Mar 9, 2017. Each investigator has a profile showing what they cite most.
When was Altaire Pharmaceuticals Inc. inspected by FDA?
The inspection ran Feb 27 – Mar 9, 2017, and the Form 483 is dated March 9, 2017.
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.