Form FDA 483 · Issued 2026-01-14
US Specialty Formulations LLC — FDA Form 483 Analysis
FEI: 3010680515 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to US Specialty Formulations LLC (FEI 3010680515) on 2026-01-14 following an inspection of its outsourcing facility operations in Pennsylvania. The report documents 2 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 (2)
Observation #1 · 21 CFR 211.110(d)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Rejected in-process materials not quarantined
Inspector Observation Language: "Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable. Specifically, observed during inspection of US Specialty Formulations LLC on 2026-01-14."
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 211.56(b)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Written sanitation procedures not followed
Inspector Observation Language: "Written procedures for sanitation are not followed. Specifically, observed during inspection of US Specialty Formulations LLC on 2026-01-14."
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.