Kutol Products Company
Form 483 issued March 3, 2020 · SHARONVILLE, Ohio
- Inspection
- Feb 20 – Mar 3, 2020
- Investigator
- Jon P. Antoniou
- Observations
- 7
- Pages
- 5
- FEI number
- 1513988
In short: On March 3, 2020, FDA issued a Form 483 with 7 observations to Kutol Products Company in SHARONVILLE, Ohio (FEI 1513988) after an inspection that ran Feb 20 – Mar 3, 2020. The investigator was Jon P. Antoniou. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Deviations from written production and process control…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Jon P. Antoniou
4 documents · 2019–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmKutol Products Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kutol Products Company?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Kutol Products Company?
Jon P. Antoniou is named on this Form 483, for the inspection of Feb 20 – Mar 3, 2020. Each investigator has a profile showing what they cite most.
When was Kutol Products Company inspected by FDA?
The inspection ran Feb 20 – Mar 3, 2020, and the Form 483 is dated March 3, 2020.
How do I get the full Form 483 for Kutol Products Company?
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.