Kingston Pharma LLC
Form 483 issued September 15, 2021 · Massena, New York
- Inspection
- Sep 7 – Sep 15, 2021
- Investigator
- Junho Pak
- Observations
- 11
- Pages
- 11
- FEI number
- 3012275336
In short: On September 15, 2021, FDA issued a Form 483 with 11 observations to Kingston Pharma LLC in Massena, New York (FEI 3012275336) after an inspection that ran Sep 7 – Sep 15, 2021. The investigator was Junho Pak. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
EHPLOVEEI) SGNATURE 7 The responsibilities and procedures applicable to the quality control unit are not in…
- 04
EHPLOVEEI) SGNATURE 7 Written procedures are not established and followed that describe the in-process controls and…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kingston Pharma LLC?
FDA listed 11 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Kingston Pharma LLC?
Junho Pak is named on this Form 483, for the inspection of Sep 7 – Sep 15, 2021. Each investigator has a profile showing what they cite most.
When was Kingston Pharma LLC inspected by FDA?
The inspection ran Sep 7 – Sep 15, 2021, and the Form 483 is dated September 15, 2021.
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.