Kingston Pharma LLC
Form 483 issued September 21, 2023 · Massena, New York
- Inspection
- Aug 14 – Sep 21, 2023
- Investigators
- Edmund F. Mrak· Ogechi C. Nna
- Observations
- 8
- Pages
- 23
- FEI number
- 3012275336
In short: On September 21, 2023, FDA issued a Form 483 with 8 observations to Kingston Pharma LLC in Massena, New York (FEI 3012275336) after an inspection that ran Aug 14 – Sep 21, 2023. The investigators were Edmund F. Mrak and Ogechi C. Nna. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Facilities & equipment and materials account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmKingston Pharma LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kingston Pharma LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Kingston Pharma LLC?
Edmund F. Mrak and Ogechi C. Nna are named on this Form 483, for the inspection of Aug 14 – Sep 21, 2023. Each investigator has a profile showing what they cite most.
When was Kingston Pharma LLC inspected by FDA?
The inspection ran Aug 14 – Sep 21, 2023, and the Form 483 is dated September 21, 2023.
How do I get the full Form 483 for Kingston Pharma LLC?
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