Chemrite Copac LLC
Form 483 issued April 11, 2023 · Lannon, Wisconsin
- Inspection
- Apr 11, 2023
- Investigators
- Ichele L. Pisit· Michele L. Glendenning
- Observations
- 6
- Pages
- 6
- FEI number
- 2131087
In short: On April 11, 2023, FDA issued a Form 483 with 6 observations to Chemrite Copac LLC in Lannon, Wisconsin (FEI 2131087) after an inspection that ran Apr 11, 2023. The investigators were Ichele L. Pisit and Michele L. Glendenning. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm does not have an adequate number of qualified personnel to perform and supervise the…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 03
Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
This inspection in context
Ichele L. Pisit
1 document · 2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
The firmChemrite Copac LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chemrite Copac LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Chemrite Copac LLC?
Ichele L. Pisit and Michele L. Glendenning are named on this Form 483, for the inspection of Apr 11, 2023. Each investigator has a profile showing what they cite most.
When was Chemrite Copac LLC inspected by FDA?
The inspection ran Apr 11, 2023, and the Form 483 is dated April 11, 2023.
How do I get the full Form 483 for Chemrite Copac 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.