Continental Manufacturing Chemist
Form 483 issued May 10, 2023 · Huxley, Iowa
- Inspection
- May 1 – May 10, 2023
- Investigator
- Torrey M. Ward
- Observations
- 4
- Pages
- 4
- FEI number
- 3014469173
In short: On May 10, 2023, FDA issued a Form 483 with 4 observations to Continental Manufacturing Chemist in Huxley, Iowa (FEI 3014469173) after an inspection that ran May 1 – May 10, 2023. The investigator was Torrey M. Ward. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and facilities & equipment account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Representative samples are not taken of each shipment of each lot of components…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Torrey M. Ward
13 documents · 2021–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Iowa.
The firmContinental Manufacturing Chemist history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Continental Manufacturing Chemist?
FDA listed 4 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Continental Manufacturing Chemist?
Torrey M. Ward is named on this Form 483, for the inspection of May 1 – May 10, 2023. Each investigator has a profile showing what they cite most.
When was Continental Manufacturing Chemist inspected by FDA?
The inspection ran May 1 – May 10, 2023, and the Form 483 is dated May 10, 2023.
How do I get the full Form 483 for Continental Manufacturing Chemist?
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.