PQ Pharmacy LLC
Form 483 issued April 4, 2025 · Brooksville, Florida
- Inspection
- Mar 25 – Apr 4, 2025
- Investigators
- Jose R. Lopez· Jose R. Martinez
- Observations
- 4
- Pages
- 9
- FEI number
- 3017374013
In short: On April 4, 2025, FDA issued a Form 483 with 4 observations to PQ Pharmacy LLC in Brooksville, Florida (FEI 3017374013) after an inspection that ran Mar 25 – Apr 4, 2025. The investigators were Jose R. Lopez and Jose R. Martinez. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your fnm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Jose R. Lopez
7 documents · 2010–2026
Cites 211.100 (written procedures; deviations) 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PQ Pharmacy LLC?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected PQ Pharmacy LLC?
Jose R. Lopez and Jose R. Martinez are named on this Form 483, for the inspection of Mar 25 – Apr 4, 2025. Each investigator has a profile showing what they cite most.
When was PQ Pharmacy LLC inspected by FDA?
The inspection ran Mar 25 – Apr 4, 2025, and the Form 483 is dated April 4, 2025.
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.