Pine Pharmaceuticals, LLC
FDA inspection history in Tonawanda, New York, 2015 to 2026
- 6
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2015: one Form 483; 2016: one warning letter; 2018: one Form 483; 2021: one Form 483; 2023: one Form 483; 2024: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s and one warning letter, at Tonawanda, New York.
- 2021–26Four Form 483s and one warning letter, at Tonawanda, New York.
- 2024The longest 483 on file: 9 observations over 13 pages at Tonawanda, New York.
Cited most
Across all Pine Pharmaceuticals observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review5
- 21 CFR 211.42Design and construction features5
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.100Written procedures; deviations2
The complete Pine Pharmaceuticals file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Tonawanda, New York
Six Form 483s and two warning letters · 2015 to 2026 · 34 observations
Latest: Warning letter, Aug 7, 2026 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-07 | Warning letter Warning letter | Tonawanda, New York | — | $99 |
| 2025-11-14 | 483 Form 483 | Tonawanda, New York | 5 | $99 |
| 2024-09-30 | 483 Form 483 | Tonawanda, New York | 9 | $99 |
| 2023-09-19 | 483 Form 483 | Tonawanda, New York | 7 | $99 |
| 2021-05-14 | 483 Form 483 | Tonawanda, New York | 5 | $99 |
| 2018-04-26 | 483 Form 483 | Tonawanda, New York | 3 | $99 |
| 2016-11-07 | Warning letter Warning letter | Tonawanda, New York | — | $99 |
| 2015-10-23 | 483 Form 483 | Tonawanda, New York | 5 | $99 |
Investigators on these documents
Mindy M. Chou (2)James A. Liubicich (1)Jazmine N. Brown (1)Johnna L. Bleem (1)Jordan S. Burkdoll (1)Lauren H. Augustyniak (1)Logan T. Williams (1)Rachael Moliver (1)Simone E. Pitts (1)Tekalign Wondimu (1)Anna M. Spiros (1)Ucheabuchi C. Chudi-Nwankwor (1)
FEI number 3010943533 · most recent document Aug 7, 2026
About Pine Pharmaceuticals, LLC
How many FDA Form 483s has Pine Pharmaceuticals, LLC received?
FDA Intel has 6 Form 483s on file for Pine Pharmaceuticals, LLC; the most recent is dated Nov 14, 2025.
When was Pine Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Pine Pharmaceuticals, LLC is a Form 483 dated Nov 14, 2025, for the site in Tonawanda, New York.
What did FDA cite at Pine Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Pine Pharmaceuticals, LLC are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.42 (Design and construction features), 5 times.
Has Pine Pharmaceuticals, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Pine Pharmaceuticals, LLC; the most recent is dated Aug 7, 2026.