PQ Pharmacy LLC
Form 483 issued October 27, 2022 · Brooksville, Florida
- Inspection
- Oct 11 – Oct 27, 2022
- Investigators
- Joanne E. King· Kayla V. Sprague
- Observations
- 7
- Pages
- 7
- FEI number
- 3017374013
In short: On October 27, 2022, FDA issued a Form 483 with 7 observations to PQ Pharmacy LLC in Brooksville, Florida (FEI 3017374013) after an inspection that ran Oct 11 – Oct 27, 2022. The investigators were Joanne E. King and Kayla V. Sprague. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 3 systems, led by quality system.
Most cited: FDCA 503B(b)(2)(A) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
An adequate number of batches of each drug product are not tested nor are records of…
- 04
The written stability program for diug products does not…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmPQ Pharmacy LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PQ Pharmacy LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected PQ Pharmacy LLC?
Joanne E. King and Kayla V. Sprague are named on this Form 483, for the inspection of Oct 11 – Oct 27, 2022. Each investigator has a profile showing what they cite most.
When was PQ Pharmacy LLC inspected by FDA?
The inspection ran Oct 11 – Oct 27, 2022, and the Form 483 is dated October 27, 2022.
How do I get the full Form 483 for PQ Pharmacy LLC?
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.