Chemrite Copac LLC
Form 483 issued March 24, 2016 · Lannon, Wisconsin
- Inspection
- Mar 9 – Mar 24, 2016
- Investigators
- Jesse P. Romenesko· Shalonda C. Clifford
- Observations
- 6
- Pages
- 5
- FEI number
- 2131087
In short: On March 24, 2016, FDA issued a Form 483 with 6 observations to Chemrite Copac LLC in Lannon, Wisconsin (FEI 2131087) after an inspection that ran Mar 9 – Mar 24, 2016. The investigators were Jesse P. Romenesko and Shalonda C. Clifford. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
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
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 04
The use of instruments not meeting…
This inspection in context
Jesse P. Romenesko
1 document · 2016
Cites 211.67(b) (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 211.22(c)
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 facilities & equipment, laboratory controls and quality system. 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?
Jesse P. Romenesko and Shalonda C. Clifford are named on this Form 483, for the inspection of Mar 9 – Mar 24, 2016. Each investigator has a profile showing what they cite most.
When was Chemrite Copac LLC inspected by FDA?
The inspection ran Mar 9 – Mar 24, 2016, and the Form 483 is dated March 24, 2016.
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.