Westlab Pharmacy Inc.
Form 483 issued August 15, 2018 · Gainesville, Florida
- Inspection
- Aug 6 – Aug 15, 2018
- Investigator
- Jennifer L. Huntington
- Observations
- 9
- Pages
- 5
- FEI number
- 3007426960
In short: On August 15, 2018, FDA issued a Form 483 with 9 observations to Westlab Pharmacy Inc. in Gainesville, Florida (FEI 3007426960) after an inspection that ran Aug 6 – Aug 15, 2018. The investigator was Jennifer L. Huntington. Most observations concern materials and laboratory controls.
At a glance
Observations span 3 systems, led by materials.
Most cited: FDCA 501(a)(2)(A) (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing area was located within a non-classified…
- 02FDCA 501(a)(2)(A)
Observation 2: scanned text, readable in the full document.
- 03
You used a non-pharmaceutical grade component in the formulation…
- 04FDCA 501(a)(2)(A)
Personnel engaged in aseptic processing were…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Westlab Pharmacy Inc.?
FDA listed 9 observations on this Form 483, mostly about materials, laboratory controls and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Westlab Pharmacy Inc.?
Jennifer L. Huntington is named on this Form 483, for the inspection of Aug 6 – Aug 15, 2018. Each investigator has a profile showing what they cite most.
When was Westlab Pharmacy Inc. inspected by FDA?
The inspection ran Aug 6 – Aug 15, 2018, and the Form 483 is dated August 15, 2018.
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.