Form FDA 483 · Issued 2026-09-03
OPS International Inc dba Olympia Pharmaceuticals — FDA Form 483 Analysis
FEI: 3009724085 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to OPS International Inc dba Olympia Pharmaceuticals (FEI 3009724085) on 2026-09-03 following an inspection of its outsourcing facility operations in Florida. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.67(a)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Cleaning / Sanitizing / Maintenance
Inspector Observation Language: "Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, observed during inspection of OPS International Inc dba Olympia Pharmaceuticals on 2026-09-03."
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.
Observation #2 · 21 CFR 211.67(b)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Written procedures not established/followed
Inspector Observation Language: "Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, observed during inspection of OPS International Inc dba Olympia Pharmaceuticals on 2026-09-03."
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.