Chemrite Copac LLC
FDA inspection history in Lannon, Wisconsin, 2013 to 2023
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2013: one Form 483; 2016: one Form 483; 2017: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One Form 483, at Lannon, Wisconsin.
- 2013The longest 483 on file: 11 observations over 6 pages at Lannon, Wisconsin.
- 2016–17One Form 483 and one warning letter, at Lannon, Wisconsin.
- 2023One Form 483, at Lannon, Wisconsin.
Cited most
Across all Chemrite Copac observations on file
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements3
- 21 CFR 211.22(b)Responsibilities of quality control unit3
- 21 CFR 211.125(c)Labeling issuance1
The complete Chemrite Copac file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Lannon, Wisconsin
Three Form 483s and one warning letter · 2013 to 2023 · 23 observations
Latest: Form 483, Apr 11, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-11 | 483 Form 483 | Lannon, Wisconsin | 6 | $99 |
| 2017-06-29 | Warning letter Warning letter | Lannon, Wisconsin | — | $99 |
| 2016-03-24 | 483 Form 483 | Lannon, Wisconsin | 6 | $99 |
| 2013-02-21 | 483 Form 483 | Lannon, Wisconsin | 11 | $99 |
Investigators on these documents
Ichele L. Pisit (1)Jesse P. Romenesko (1)Michele L. Glendenning (1)Sandra A. Hughes (1)Shalonda C. Clifford (1)
FEI number 2131087 · most recent document Apr 11, 2023
About Chemrite Copac LLC
How many FDA Form 483s has Chemrite Copac LLC received?
FDA Intel has 3 Form 483s on file for Chemrite Copac LLC; the most recent is dated Apr 11, 2023.
When was Chemrite Copac LLC last inspected by FDA?
The most recent FDA inspection document on file for Chemrite Copac LLC is a Form 483 dated Apr 11, 2023, for the site in Lannon, Wisconsin.
What did FDA cite at Chemrite Copac LLC?
The regulations cited most in the observations on file for Chemrite Copac LLC are 21 CFR 211.67 (Equipment cleaning and maintenance), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.160 (General requirements), 3 times.
Has Chemrite Copac LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Chemrite Copac LLC; the most recent is dated Jun 29, 2017.