Form 483 · FEI 1972829
Form 483 issued August 14, 2014 · Fenton, Missouri
- Inspection
- Aug 4 – Aug 14, 2014
- Investigator
- Shirley J. Berryman
- Observations
- 10
- Pages
- 3
- FEI number
- 1972829
In short: On August 14, 2014, FDA issued a Form 483 with 10 observations to an FDA-inspected site in Fenton, Missouri (FEI 1972829) after an inspection that ran Aug 4 – Aug 14, 2014. The investigator was Shirley J. Berryman. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 7 of 10 observations.
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
Clothing o f personnel engaged in compounding drug activities is not appropriate for…
- 02
Procedures designed to prevent microbiological contamination of compounded drug products purporting to be…
- 03
You have failed to conduct Environmental Monitoring in your lSO 5, IV rooms (where…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Shirley J. Berryman
7 documents · 2007–2014
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
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 production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Shirley J. Berryman is named on this Form 483, for the inspection of Aug 4 – Aug 14, 2014. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 4 – Aug 14, 2014, and the Form 483 is dated August 14, 2014.
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.