Continental Manufacturing Chemist, Inc. 12/21/17
Form 483 issued May 10, 2023 · Madrid, Iowa
- Inspection
- May 3 – May 10, 2023
- Investigator
- Torrey M. Ward
- Observations
- 3
- Pages
- 3
- FEI number
- 1910648
In short: On May 10, 2023, FDA issued a Form 483 with 3 observations to Continental Manufacturing Chemist, Inc. 12/21/17 in Madrid, Iowa (FEI 1910648) after an inspection that ran May 3 – May 10, 2023. The investigator was Torrey M. Ward. Most observations concern materials and laboratory controls.
At a glance
Materials and laboratory controls account for 2 of 3 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
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Written procedures are not established 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, Inc. 12/21/17 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, Inc. 12/21/17?
FDA listed 3 observations on this Form 483, mostly about materials, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Continental Manufacturing Chemist, Inc. 12/21/17?
Torrey M. Ward is named on this Form 483, for the inspection of May 3 – May 10, 2023. Each investigator has a profile showing what they cite most.
When was Continental Manufacturing Chemist, Inc. 12/21/17 inspected by FDA?
The inspection ran May 3 – May 10, 2023, and the Form 483 is dated May 10, 2023.
How do I get the full Form 483 for Continental Manufacturing Chemist, Inc. 12/21/17?
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.