Form FDA 483 · Issued 2025-10-20
WS Audiology USA Inc. — FDA Form 483 Analysis
FEI: 2430101 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to WS Audiology USA Inc. (FEI 2430101) on 2025-10-20 following an inspection of its manufacturer operations in New York. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.194(e)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Stability testing records not included
Inspector Observation Language: "Laboratory records do not include complete records of all stability testing performed. Specifically, observed during inspection of WS Audiology USA Inc. on 2025-10-20."
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 211.198(b)(1)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Complaint Record required information
Inspector Observation Language: "Complaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant]. Specifically, observed during inspection of WS Audiology USA Inc. on 2025-10-20."
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.
Observation #3 · 21 CFR 211.56(c)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Written procedures lacking for use of pesticides etc.
Inspector Observation Language: "Written procedures are lacking for the use of [rodenticides] [insecticides] [fungicides] [fumigating agents] [cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components] [drug product containers] [closures] [packaging, labeling materials] [drug products]. Specifically, observed during inspection of WS Audiology USA Inc. on 2025-10-20."
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.