Form 483 · FEI 1972829
Form 483 issued November 16, 2017 · Fenton, Missouri
- Inspection
- Oct 23 – Nov 16, 2017
- Investigator
- Tiara N. Brown-Crosen
- Observations
- 6
- Pages
- 4
- FEI number
- 1972829
In short: On November 16, 2017, FDA issued a Form 483 with 6 observations to an FDA-inspected site in Fenton, Missouri (FEI 1972829) after an inspection that ran Oct 23 – Nov 16, 2017. The investigator was Tiara N. Brown-Crosen. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of an unexplained discrepancy did not extend to other batches of…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Results of stability testing are not used…
This inspection in context
Tiara N. Brown-Crosen
7 documents · 2016–2019
Cites 211.166 (stability testing) 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 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Tiara N. Brown-Crosen is named on this Form 483, for the inspection of Oct 23 – Nov 16, 2017. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Oct 23 – Nov 16, 2017, and the Form 483 is dated November 16, 2017.
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.