Form 483 · FEI 3011103365
Form 483 issued February 7, 2020 · Brooksville, Florida
- Inspection
- Feb 5 – Feb 7, 2020
- Investigator
- Jessica L. Pressley
- Observations
- 2
- Pages
- 1
- FEI number
- 3011103365
In short: On February 7, 2020, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Brooksville, Florida (FEI 3011103365) after an inspection that ran Feb 5 – Feb 7, 2020. The investigator was Jessica L. Pressley. Most observations concern facilities & equipment.
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-microbial contamination was observed…
- 02
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmSite history
The site's inspection history, in date order.
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 2 observations on this Form 483, mostly about facilities & equipment. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Jessica L. Pressley is named on this Form 483, for the inspection of Feb 5 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 5 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
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.