Form FDA 483 · Issued 2026-03-23
Cerovene Inc. — FDA Form 483 Analysis
FEI: 3005890568 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Contract Drug Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Cerovene Inc. (FEI 3005890568) on 2026-03-23 following an inspection of its contract drug manufacturer operations in New York. The report documents 5 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.192
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Quality control unit review of records
Inspector Observation Language: "Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Specifically, observed during inspection of Cerovene Inc. on 2026-03-23."
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 #2 · 21 CFR 211.194(a)(8)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Second person sign off
Inspector Observation Language: "Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for [accuracy] [completeness] [compliance with established standards]. Specifically, observed during inspection of Cerovene Inc. on 2026-03-23."
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 #3 · 21 CFR 211.22(a)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Approve or reject components, products
Inspector Observation Language: "The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug product containers] [closures] [in process materials] [packaging material] [labeling] [drug products]. Specifically, observed during inspection of Cerovene Inc. on 2026-03-23."
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 211.160(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Lab controls established, including changes
Inspector Observation Language: "The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, observed during inspection of Cerovene Inc. on 2026-03-23."
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 #5 · 21 CFR 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Backup data not assured as exact and complete
Inspector Observation Language: "Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, observed during inspection of Cerovene Inc. on 2026-03-23."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.