Form FDA 483 · Issued 2026-03-13
Jeffrey R. Hoodin, M.D. — FDA Form 483 Analysis
FEI: 3042366712 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Clinical Investigator) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Jeffrey R. Hoodin, M.D. (FEI 3042366712) on 2026-03-13 following an inspection of its clinical investigator operations in Arizona. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.111
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Establishment of time limitations
Inspector Observation Language: "Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, observed during inspection of Jeffrey R. Hoodin, M.D. on 2026-03-13."
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.
Observation #2 · 21 CFR 211.165(f)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Failing drug products not rejected
Inspector Observation Language: "Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, observed during inspection of Jeffrey R. Hoodin, M.D. on 2026-03-13."
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 314.81(b)(2)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Timely submission
Inspector Observation Language: "An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval of the application] to the FDA division responsible for reviewing the application. Specifically, observed during inspection of Jeffrey R. Hoodin, M.D. on 2026-03-13."
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.
Observation #4 · FDCA 503B(a)(10)(A)
Label Control, Undeclared Allergens & Structure/Function Claims
REPEAT CITATION AT FACILITY
Drug product labels, fails to include
Inspector Observation Language: "The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, observed during inspection of Jeffrey R. Hoodin, M.D. on 2026-03-13."
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 #5 · 21 CFR 211.188(b)(2)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Identification of Equipment and Lines
Inspector Observation Language: "The batch production and control records are deficient in that they do not include the identity of major [equipment] [lines] used. Specifically, observed during inspection of Jeffrey R. Hoodin, M.D. on 2026-03-13."
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.