Form FDA 483 · Issued 2026-06-01
PQ Pharmacy LLC — FDA Form 483 Analysis
FEI: 3017374013 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to PQ Pharmacy LLC (FEI 3017374013) on 2026-06-01 following an inspection of its outsourcing facility operations in Florida. The report documents 3 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.25(a)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Training--operations, GMPs, written procedures
Inspector Observation Language: "Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. Specifically, observed during inspection of PQ Pharmacy LLC on 2026-06-01."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #2 · 21 CFR 211.100(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
SOPs not followed / documented
Inspector Observation Language: "Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, observed during inspection of PQ Pharmacy LLC on 2026-06-01."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #3 · 21 CFR 211.142(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Storage under appropriate conditions
Inspector Observation Language: "Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected. Specifically, observed during inspection of PQ Pharmacy LLC on 2026-06-01."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.