Form FDA 483 · Issued 2026-03-03
Dennis J . Hsu, M.D. — FDA Form 483 Analysis
FEI: 3042047166 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Clinical Investigator) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Dennis J . Hsu, M.D. (FEI 3042047166) on 2026-03-03 following an inspection of its clinical investigator operations in Pennsylvania. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.28(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Protective Apparel Not Worn
Inspector Observation Language: "Protective apparel is not worn as necessary to protect drug products from contamination. Specifically, observed during inspection of Dennis J . Hsu, M.D. on 2026-03-03."
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.
Observation #2 · 21 CFR 211.84(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Representative Samples Criteria
Inspector Observation Language: "The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria. Specifically, observed during inspection of Dennis J . Hsu, M.D. on 2026-03-03."
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 #3 · 21 CFR 211.166(c)(1)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Homeopathic drugs, assessment of stability
Inspector Observation Language: "There is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use]. Specifically, observed during inspection of Dennis J . Hsu, M.D. on 2026-03-03."
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 #4 · 21 CFR 211.186(b)(9)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Manufacturing Instructions and Specifications
Inspector Observation Language: "The master production and control records are deficient in that they do not include complete [manufacturing and control instructions] [sampling procedures] [testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, observed during inspection of Dennis J . Hsu, M.D. on 2026-03-03."
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 211.186(b)(9)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Complete instructions, procedures, specifications et. al.
Inspector Observation Language: "Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, observed during inspection of Dennis J . Hsu, M.D. on 2026-03-03."
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.