Form FDA 483 · Issued 2025-11-21
Pharmathen International S.A. — FDA Form 483 Analysis
FEI: 3009961173 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Finished Pharmaceutical Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Pharmathen International S.A. (FEI 3009961173) on 2025-11-21 following an inspection of its finished pharmaceutical manufacturer operations in Greece. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Label Control, Undeclared Allergens & Structure/Function Claims.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.122(b)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Labeling and packaging improperly approved/released
Inspector Observation Language: "Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use]. Specifically, observed during inspection of Pharmathen International S.A. on 2025-11-21."
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 #2 · 21 CFR 211.130(e)
Label Control, Undeclared Allergens & Structure/Function Claims
REPEAT CITATION AT FACILITY
Packaging line inspection after use
Inspector Observation Language: "Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have been removed. Specifically, observed during inspection of Pharmathen International S.A. on 2025-11-21."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #3 · 21 CFR 211.80(d)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Disposition recorded by lot identification
Inspector Observation Language: "The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot. Specifically, observed during inspection of Pharmathen International S.A. on 2025-11-21."
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 #4 · 21 CFR 211.94(c)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Containers & Closures Clean, Sterilized, Pyrogen-free
Inspector Observation Language: "Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use. Specifically, observed during inspection of Pharmathen International S.A. on 2025-11-21."
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 #5 · 21 CFR 211.180(f)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Responsible firm officials notified in writing
Inspector Observation Language: "Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices]. Specifically, observed during inspection of Pharmathen International S.A. on 2025-11-21."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.