FDA-Inspected Site

PQ Pharmacy LLC

2 FDA inspections are on record for PQ Pharmacy LLC in Brooksville, United States.

483· Form 483 issued

Brooksville, United States · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-04.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 Mar 2025 – 4 Apr 2025Human DrugsWLView 483 →
11 Oct 2022 – 27 Oct 2022Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

4 Apr 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Jose R Lopez

4 Apr 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Jose R Lopez

4 Apr 2025
21 CFR 211.192

Written record of investigation incomplete

Cited by Jose R Lopez

4 Apr 2025
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Jose R Lopez

27 Oct 2022
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Joanne E King, Kayla V Sprague

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
FDCA 503B(b)(2)(A)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.166(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind PQ Pharmacy LLC's 2 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat