Apex International Mfg., LLC
Form 483 issued August 11, 2023 · Chaska, Minnesota
- Inspection
- Aug 7 – Aug 11, 2023
- Investigator
- Monica E. Murie
- Observations
- 3
- Pages
- 4
- FEI number
- 2130334
In short: On August 11, 2023, FDA issued a Form 483 with 3 observations to Apex International Mfg., LLC in Chaska, Minnesota (FEI 2130334) after an inspection that ran Aug 7 – Aug 11, 2023. The investigator was Monica E. Murie. Most observations concern facilities & equipment and materials.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Written procedures are not established or followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Monica E. Murie
11 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
The firmApex International Mfg., LLC 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apex International Mfg., LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Apex International Mfg., LLC?
Monica E. Murie is named on this Form 483, for the inspection of Aug 7 – Aug 11, 2023. Each investigator has a profile showing what they cite most.
When was Apex International Mfg., LLC inspected by FDA?
The inspection ran Aug 7 – Aug 11, 2023, and the Form 483 is dated August 11, 2023.
How do I get the full Form 483 for Apex International Mfg., 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.