Form 483 · FEI 1972829
Form 483 issued September 28, 2021 · Fenton, Missouri
- Inspection
- Sep 16 – Sep 28, 2021
- Investigator
- Wayne D. McGrath
- Observations
- 4
- Pages
- 8
- FEI number
- 1972829
In short: On September 28, 2021, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Fenton, Missouri (FEI 1972829) after an inspection that ran Sep 16 – Sep 28, 2021. The investigator was Wayne D. McGrath. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into the failure of a batch or any of its components to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Written procedmes are lacking which describe in sufficient detail the receipt, identification, testing, approval and rejection…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Wayne D. McGrath is named on this Form 483, for the inspection of Sep 16 – Sep 28, 2021. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 16 – Sep 28, 2021, and the Form 483 is dated September 28, 2021.
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.