Form 483 · FEI 1972829
Form 483 issued August 28, 2019 · Fenton, Missouri
- Inspection
- Aug 20 – Aug 28, 2019
- Investigator
- Mindy M. Chou
- Observations
- 8
- Pages
- 5
- FEI number
- 1972829
In short: On August 28, 2019, FDA issued a Form 483 with 8 observations to an FDA-inspected site in Fenton, Missouri (FEI 1972829) after an inspection that ran Aug 20 – Aug 28, 2019. The investigator was Mindy M. Chou. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmSite history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Mindy M. Chou is named on this Form 483, for the inspection of Aug 20 – Aug 28, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 20 – Aug 28, 2019, and the Form 483 is dated August 28, 2019.
How do I get the full Form 483 for an FDA-inspected site?
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.