Form FDA 483 · Issued 2025-10-30
SCA Pharmaceuticals Inc — FDA Form 483 Analysis
FEI: 3010683157 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to SCA Pharmaceuticals Inc (FEI 3010683157) on 2025-10-30 following an inspection of its outsourcing facility operations in Arkansas. The report documents 2 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.182
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Personnel dating/signing equipment log
Inspector Observation Language: "The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log. Specifically, observed during inspection of SCA Pharmaceuticals Inc on 2025-10-30."
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 #2 · 21 CFR 211.188(b)(10)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Documentation of Sampling Performed
Inspector Observation Language: "The batch production and control records are deficient in that they do not include documentation of sampling performed. Specifically, observed during inspection of SCA Pharmaceuticals Inc on 2025-10-30."
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.