Chemrite Copac LLC
Form 483 issued February 21, 2013 · Lannon, Wisconsin
- Inspection
- Feb 7 – Feb 21, 2013
- Investigator
- Sandra A. Hughes
- Observations
- 11
- Pages
- 6
- FEI number
- 2131087
In short: On February 21, 2013, FDA issued a Form 483 with 11 observations to Chemrite Copac LLC in Lannon, Wisconsin (FEI 2131087) after an inspection that ran Feb 7 – Feb 21, 2013. The investigator was Sandra A. Hughes. Most observations concern cAPA and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by capa.
Most cited: 21 CFR 211.67(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Products that do not conform to specifications…
- 02
Procedures for corrective and preventive action have…
- 03
Written MDR procedures have not been…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
This inspection in context
Sandra A. Hughes
23 documents · 2009–2019
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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chemrite Copac LLC?
FDA listed 11 observations on this Form 483, mostly about cAPA, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Chemrite Copac LLC?
Sandra A. Hughes is named on this Form 483, for the inspection of Feb 7 – Feb 21, 2013. Each investigator has a profile showing what they cite most.
When was Chemrite Copac LLC inspected by FDA?
The inspection ran Feb 7 – Feb 21, 2013, and the Form 483 is dated February 21, 2013.
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.