Premier Pharmacy Labs Inc.
Form 483 issued June 13, 2016 · WEEKI WACHEE, Florida
- Inspection
- Jun 6 – Jun 13, 2016
- Investigators
- Ileana Barreto-Pettit· Noreen Muniz
- Observations
- 11
- Pages
- 7
- FEI number
- 3007271263
In short: On June 13, 2016, FDA issued a Form 483 with 11 observations to Premier Pharmacy Labs Inc. in WEEKI WACHEE, Florida (FEI 3007271263) after an inspection that ran Jun 6 – Jun 13, 2016. The investigators were Ileana Barreto-Pettit and Noreen Muniz. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
- 03
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Premier Pharmacy Labs Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. 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.?
Ileana Barreto-Pettit and Noreen Muniz are named on this Form 483, for the inspection of Jun 6 – Jun 13, 2016. Each investigator has a profile showing what they cite most.
When was Premier Pharmacy Labs Inc. inspected by FDA?
The inspection ran Jun 6 – Jun 13, 2016, and the Form 483 is dated June 13, 2016.
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.