United Pharmacy, LLC
Form 483 issued August 18, 2017 · West Palm Beach, Florida
- Inspection
- May 27, 2016
- Investigator
- Jessica L. Pressley
- Observations
- 8
- Pages
- 4
- FEI number
- 3010404505
In short: On August 18, 2017, FDA issued a Form 483 with 8 observations to United Pharmacy, LLC in West Palm Beach, Florida (FEI 3010404505) after an inspection that ran May 27, 2016. The investigator was Jessica L. Pressley. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
7 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (7×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic…
- 02
Your firm released drug product in which the strength differs from, or its purity or quality…
- 03
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 04
Personnel failed to disinfect or change gloves frequently…
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 firmUnited Pharmacy, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at United Pharmacy, LLC?
FDA listed 8 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected United Pharmacy, LLC?
Jessica L. Pressley is named on this Form 483, for the inspection of May 27, 2016. Each investigator has a profile showing what they cite most.
When was United Pharmacy, LLC inspected by FDA?
The inspection ran May 27, 2016, and the Form 483 is dated August 18, 2017.
How do I get the full Form 483 for United Pharmacy, LLC?
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.