Kingston Pharma LLC
Form 483 issued December 10, 2018 · Massena, New York
- Inspection
- Nov 13 – Dec 10, 2018
- Investigator
- Edmund F. Mrak
- Observations
- 1
- Pages
- 17
- FEI number
- 3012275336
In short: On December 10, 2018, FDA issued a Form 483 with 1 observation to Kingston Pharma LLC in Massena, New York (FEI 3012275336) after an inspection that ran Nov 13 – Dec 10, 2018. The investigator was Edmund F. Mrak. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kingston Pharma LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Kingston Pharma LLC?
Edmund F. Mrak is named on this Form 483, for the inspection of Nov 13 – Dec 10, 2018. Each investigator has a profile showing what they cite most.
When was Kingston Pharma LLC inspected by FDA?
The inspection ran Nov 13 – Dec 10, 2018, and the Form 483 is dated December 10, 2018.
How do I get the full Form 483 for Kingston Pharma LLC?
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.