Kesin Pharma
Form 483 issued January 19, 2024 · Oldsmar, Florida
- Inspection
- Jan 17 – Jan 19, 2024
- Investigators
- Dorothy P. Kramer· Nicole E. Knowlton
- Observations
- 6
- Pages
- 4
- FEI number
- 3016965788
In short: On January 19, 2024, FDA issued a Form 483 with 6 observations to Kesin Pharma in Oldsmar, Florida (FEI 3016965788) after an inspection that ran Jan 17 – Jan 19, 2024. The investigators were Dorothy P. Kramer and Nicole E. Knowlton. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Yom firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to…
This inspection in context
Dorothy P. Kramer
9 documents · 2022–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmKesin Pharma history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kesin Pharma?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Kesin Pharma?
Dorothy P. Kramer and Nicole E. Knowlton are named on this Form 483, for the inspection of Jan 17 – Jan 19, 2024. Each investigator has a profile showing what they cite most.
When was Kesin Pharma inspected by FDA?
The inspection ran Jan 17 – Jan 19, 2024, and the Form 483 is dated January 19, 2024.
How do I get the full Form 483 for Kesin Pharma?
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.