Premier Pharmacy Labs Inc.
Form 483 issued May 9, 2014 · WEEKI WACHEE, Florida
- Inspection
- Apr 10 – May 9, 2014
- Investigator
- Michael H. Tollon
- Observations
- 15
- Pages
- 10
- FEI number
- 3007271263
In short: On May 9, 2014, FDA issued a Form 483 with 15 observations to Premier Pharmacy Labs Inc. in WEEKI WACHEE, Florida (FEI 3007271263) after an inspection that ran Apr 10 – May 9, 2014. The investigator was Michael H. Tollon. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 9 of 14 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of d.tug products purporting to be sterile are not established…
- 03
Protective apparel is not wom as necessary to protect…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Michael H. Tollon
12 documents · 2013–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmPremier Pharmacy Labs Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Premier Pharmacy Labs Inc.?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Premier Pharmacy Labs Inc.?
Michael H. Tollon is named on this Form 483, for the inspection of Apr 10 – May 9, 2014. Each investigator has a profile showing what they cite most.
When was Premier Pharmacy Labs Inc. inspected by FDA?
The inspection ran Apr 10 – May 9, 2014, and the Form 483 is dated May 9, 2014.
How do I get the full Form 483 for Premier Pharmacy Labs 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.