Kingston Pharma LLC
FDA inspection history in Massena, New York, 2018 to 2025
- 4
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2018: one Form 483; 2019: one close-out letter; 2021: one Form 483; 2023: one Form 483; 2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–25Four Form 483s, one close-out letter and one warning letter, at Massena, New York.
- 2021The longest 483 on file: 11 observations over 11 pages at Massena, New York.
Cited most
Across all Kingston Pharma observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment2
The complete Kingston Pharma file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Massena, New York
Four Form 483s, one warning letter and one close-out letter · 2018 to 2025 · 21 observations
Latest: Warning letter, Dec 1, 2025 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-01 | Warning letter Warning letter | Massena, New York | — | $99 |
| 2024-07-25 | 483 Form 483 | Massena, New York | 1 | $99 |
| 2023-09-21 | 483 Form 483 | Massena, New York | 8 | $99 |
| 2021-09-15 | 483 Form 483 | Massena, New York | 11 | $99 |
| 2019-05-14 | Close-out Close-out letter | Massena, New York | — | $99 |
| 2018-12-10 | 483 Form 483 | Massena, New York | 1 | $99 |
Investigators on these documents
FEI number 3012275336 · most recent document Dec 1, 2025
About Kingston Pharma LLC
How many FDA Form 483s has Kingston Pharma LLC received?
FDA Intel has 4 Form 483s on file for Kingston Pharma LLC; the most recent is dated Jul 25, 2024.
When was Kingston Pharma LLC last inspected by FDA?
The most recent FDA inspection document on file for Kingston Pharma LLC is a Form 483 dated Jul 25, 2024, for the site in Massena, New York.
What did FDA cite at Kingston Pharma LLC?
The regulations cited most in the observations on file for Kingston Pharma LLC are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has Kingston Pharma LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Kingston Pharma LLC; the most recent is dated Dec 1, 2025.