Cambrex Charles City, Inc.
Form 483 issued May 2, 2022 · Charles City, Iowa
- Inspection
- Apr 27 – May 2, 2022
- Investigators
- Brent M. Dehaan· Lisa L. Flores
- Observations
- 2
- Pages
- 4
- FEI number
- 1000119390
In short: On May 2, 2022, FDA issued a Form 483 with 2 observations to Cambrex Charles City, Inc. in Charles City, Iowa (FEI 1000119390) after an inspection that ran Apr 27 – May 2, 2022. The investigators were Brent M. Dehaan and Lisa L. Flores. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans, sampling…
- 02
Written records of investigations into unexplained discrepancies and failures of batches and/or components to meet specifications…
This inspection in context
Brent M. Dehaan
4 documents · 2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmCambrex Charles City, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cambrex Charles City, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cambrex Charles City, Inc.?
Brent M. Dehaan and Lisa L. Flores are named on this Form 483, for the inspection of Apr 27 – May 2, 2022. Each investigator has a profile showing what they cite most.
When was Cambrex Charles City, Inc. inspected by FDA?
The inspection ran Apr 27 – May 2, 2022, and the Form 483 is dated May 2, 2022.
How do I get the full Form 483 for Cambrex Charles City, Inc.?
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.