PQ Pharmacy LLC
Form 483 issued April 20, 2026 · Brooksville, Florida
- Inspection
- Apr 20, 2026
- Investigators
- Michael Z. Weigman· Saundrea A. Munroe
- Observations
- 7
- Pages
- 11
- FEI number
- 3017374013
In short: On April 20, 2026, FDA issued a Form 483 with 7 observations to PQ Pharmacy LLC in Brooksville, Florida (FEI 3017374013) after an inspection that ran Apr 20, 2026. The investigators were Michael Z. Weigman and Saundrea A. Munroe. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Records of the inspections of automatic, mechanical or electronic equ ipment, includ ing computers or re…
This inspection in context
Michael Z. Weigman
6 documents · 2025–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.113
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 production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected PQ Pharmacy LLC?
Michael Z. Weigman and Saundrea A. Munroe are named on this Form 483, for the inspection of Apr 20, 2026. Each investigator has a profile showing what they cite most.
When was PQ Pharmacy LLC inspected by FDA?
The inspection ran Apr 20, 2026, and the Form 483 is dated April 20, 2026.
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.