Form FDA 483 · Issued 2026-02-24
Pharmalogic Salt Lake City, LLC — FDA Form 483 Analysis
FEI: 3029497444 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Pet Drug Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Pharmalogic Salt Lake City, LLC (FEI 3029497444) on 2026-02-24 following an inspection of its pet drug manufacturer operations in Utah. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Exposed to lower quality air/ISO 5
Inspector Observation Language: "[Sterile drugs] [Materials] were exposed to lower than ISO 5 quality air. Specifically, observed during inspection of Pharmalogic Salt Lake City, LLC on 2026-02-24."
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.
Observation #2 · 21 CFR 211.67(b)(2)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Cleaning SOPs/schedules
Inspector Observation Language: "Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, observed during inspection of Pharmalogic Salt Lake City, LLC on 2026-02-24."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #3 · 21 CFR 211.42(c)(10)(iii)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Air Supply
Inspector Observation Language: "Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, observed during inspection of Pharmalogic Salt Lake City, LLC on 2026-02-24."
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.
Observation #4 · 21 CFR 211.166(a)(1)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Sample size - test intervals
Inspector Observation Language: "The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability. Specifically, observed during inspection of Pharmalogic Salt Lake City, LLC on 2026-02-24."
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 #5 · 21 CFR 211.186(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Written procedures followed
Inspector Observation Language: "Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, observed during inspection of Pharmalogic Salt Lake City, LLC on 2026-02-24."
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.