Form FDA 483 · Issued 2026-03-19
Veterinary Pharmacy Corporation — FDA Form 483 Analysis
FEI: 3002726048 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Veterinary Compounding Pharmacy) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Veterinary Pharmacy Corporation (FEI 3002726048) on 2026-03-19 following an inspection of its veterinary compounding pharmacy operations in Minnesota. The report documents 3 inspection observations centered on Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.42(c)(10)(vi)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Equipment to control conditions
Inspector Observation Language: "Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Specifically, observed during inspection of Veterinary Pharmacy Corporation on 2026-03-19."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.
Observation #2 · 21 CFR 211.166(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Results not used for expiration dates, storage cond.
Inspector Observation Language: "Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, observed during inspection of Veterinary Pharmacy Corporation on 2026-03-19."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #3 · 21 CFR 211.111
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Establishment of time limitations
Inspector Observation Language: "Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, observed during inspection of Veterinary Pharmacy Corporation on 2026-03-19."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.