Form 483 · FEI 1972829
Form 483 issued February 8, 2024 · Fenton, Missouri
- Inspection
- Jan 29 – Feb 8, 2024
- Investigators
- Lisa L. Flores· Robert J. Ham
- Observations
- 10
- Pages
- 11
- FEI number
- 1972829
In short: On February 8, 2024, FDA issued a Form 483 with 10 observations to an FDA-inspected site in Fenton, Missouri (FEI 1972829) after an inspection that ran Jan 29 – Feb 8, 2024. The investigators were Lisa L. Flores and Robert J. Ham. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
The operations relating to the processing of penicillin are not performed in facilities separate from those…
- 04
An adequate number of batches of each drug product are not tested to determine…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Lisa L. Flores and Robert J. Ham are named on this Form 483, for the inspection of Jan 29 – Feb 8, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jan 29 – Feb 8, 2024, and the Form 483 is dated February 8, 2024.
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.