Spirit Pharmaceuticals
FDA inspection history in Ronkonkoma, New York, 2017 to 2025
- 2
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2017: one Form 483; 2023: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Ronkonkoma, New York.
- 2023–25One Form 483 and one warning letter, at Ronkonkoma, New York.
- 2023The longest 483 on file: 3 observations over 4 pages at Ronkonkoma, New York.
Cited most
Across all Spirit Pharmaceuticals observations on file
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Spirit Pharmaceuticals file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Ronkonkoma, New York
Two Form 483s, one warning letter and one close-out letter · 2017 to 2025 · 5 observations
Latest: Warning letter, Mar 28, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-28 | Warning letter Warning letter | Ronkonkoma, New York | — | $99 |
| 2023-11-01 | 483 Form 483 | Ronkonkoma, New York | 3 | $99 |
| 2017-01-25 | 483 Form 483 | Ronkonkoma, New York | 2 | $99 |
| Undated | Close-out Close-out letter | Ronkonkoma, New York | — | $99 |
Investigators on these documents
FEI number 3011773798 · most recent document Mar 28, 2025
About Spirit Pharmaceuticals
How many FDA Form 483s has Spirit Pharmaceuticals received?
FDA Intel has 2 Form 483s on file for Spirit Pharmaceuticals; the most recent is dated Nov 1, 2023.
When was Spirit Pharmaceuticals last inspected by FDA?
The most recent FDA inspection document on file for Spirit Pharmaceuticals is a Form 483 dated Nov 1, 2023, for the site in Ronkonkoma, New York.
What did FDA cite at Spirit Pharmaceuticals?
The regulations cited most in the observations on file for Spirit Pharmaceuticals are 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.166(a) (Stability testing), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.
Has Spirit Pharmaceuticals received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Spirit Pharmaceuticals; the most recent is dated Mar 28, 2025.