Form FDA 483 · Issued 2026-07-03
Annovex Pharma Inc — FDA Form 483 Analysis
FEI: 3020928491 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Annovex Pharma Inc (FEI 3020928491) on 2026-07-03 following an inspection of its outsourcing facility operations in Virginia. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.84(d)(1)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Identity Testing of Each Component
Inspector Observation Language: "The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. Specifically, observed during inspection of Annovex Pharma Inc on 2026-07-03."
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 211.22(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Lack of quality control unit
Inspector Observation Language: "There is no quality control unit. Specifically, observed during inspection of Annovex Pharma Inc on 2026-07-03."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.