Westlab Pharmacy Inc.
Form 483 issued October 5, 2021 · Gainesville, Florida
- Inspection
- Sep 27 – Oct 5, 2021
- Investigator
- Jessica P. McAlister
- Observations
- 8
- Pages
- 4
- FEI number
- 3007426960
In short: On October 5, 2021, FDA issued a Form 483 with 8 observations to Westlab Pharmacy Inc. in Gainesville, Florida (FEI 3007426960) after an inspection that ran Sep 27 – Oct 5, 2021. The investigator was Jessica P. McAlister. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and production account for 7 of 8 observations.
Most cited: 21 CFR 211.56 (3×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Vermin was observed in…
- 02
Non-microbial contamination was observed…
- 03
Environmental monitoring was not performed in…
- 04
Media fi lls were not performed that closeJy s imulate aseptic production operations incorporating, as appropriate…
This inspection in context
Jessica P. McAlister
7 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmWestlab Pharmacy Inc. history
All 3 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 Westlab Pharmacy Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Westlab Pharmacy Inc.?
Jessica P. McAlister is named on this Form 483, for the inspection of Sep 27 – Oct 5, 2021. Each investigator has a profile showing what they cite most.
When was Westlab Pharmacy Inc. inspected by FDA?
The inspection ran Sep 27 – Oct 5, 2021, and the Form 483 is dated October 5, 2021.
How do I get the full Form 483 for Westlab Pharmacy Inc.?
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.