Spirit Pharmaceuticals
Form 483 issued November 1, 2023 · Ronkonkoma, New York
- Inspection
- Oct 23 – Nov 1, 2023
- Investigators
- Gam S. Zamil· Paige R. McCoy
- Observations
- 3
- Pages
- 4
- FEI number
- 3011773798
In short: On November 1, 2023, FDA issued a Form 483 with 3 observations to Spirit Pharmaceuticals in Ronkonkoma, New York (FEI 3011773798) after an inspection that ran Oct 23 – Nov 1, 2023. The investigators were Gam S. Zamil and Paige R. McCoy. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
There is no written testing program designed to assess the stability…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmSpirit Pharmaceuticals history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spirit Pharmaceuticals?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Spirit Pharmaceuticals?
Gam S. Zamil and Paige R. McCoy are named on this Form 483, for the inspection of Oct 23 – Nov 1, 2023. Each investigator has a profile showing what they cite most.
When was Spirit Pharmaceuticals inspected by FDA?
The inspection ran Oct 23 – Nov 1, 2023, and the Form 483 is dated November 1, 2023.
How do I get the full Form 483 for Spirit Pharmaceuticals?
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.