Cambrex Charles City, Inc.
Form 483 issued December 22, 2016 · Charles City, Iowa
- Inspection
- Dec 19 – Dec 22, 2016
- Investigator
- Robert J. Ham
- Observations
- 2
- Pages
- 3
- FEI number
- 1000119390
In short: On December 22, 2016, FDA issued a Form 483 with 2 observations to Cambrex Charles City, Inc. in Charles City, Iowa (FEI 1000119390) after an inspection that ran Dec 19 – Dec 22, 2016. The investigator was Robert J. Ham. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Recall Procedures are not…
- 02
Written procedures for equipment…
This inspection in context
Robert J. Ham
32 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
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 211.67
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 facilities & equipment. 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 Cambrex Charles City, Inc.?
Robert J. Ham is named on this Form 483, for the inspection of Dec 19 – Dec 22, 2016. Each investigator has a profile showing what they cite most.
When was Cambrex Charles City, Inc. inspected by FDA?
The inspection ran Dec 19 – Dec 22, 2016, and the Form 483 is dated December 22, 2016.
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.