Premier Pharmacy Labs Inc.
Form 483 issued April 29, 2020 · Weeki Wachee, Florida
- Inspection
- Apr 29, 2020
- Investigators
- Djamila Harouaka· Joanne E. King
- Observations
- 16
- Pages
- 17
- FEI number
- 3007271263
In short: On April 29, 2020, FDA issued a Form 483 with 16 observations to Premier Pharmacy Labs Inc. in Weeki Wachee, Florida (FEI 3007271263) after an inspection that ran Apr 29, 2020. The investigators were Djamila Harouaka and Joanne E. King. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 10 of 16 observations.
Most cited: 21 CFR 211.42 (6×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
EMPLOYEE($) SIGNATURE DATE lSSUEO The responsibilities and procedures applicable to the quality control unit are not…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 16 observations on this Form 483, mostly about facilities & equipment, quality system 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.?
Djamila Harouaka and Joanne E. King are named on this Form 483, for the inspection of Apr 29, 2020. Each investigator has a profile showing what they cite most.
When was Premier Pharmacy Labs Inc. inspected by FDA?
The inspection ran Apr 29, 2020, and the Form 483 is dated April 29, 2020.
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.