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Form 483 Library → Hillyard GMP → 483-3009690111-20260227
Form FDA 483 · Issued 2026-02-27

Hillyard GMP — FDA Form 483 Analysis

FEI: 3009690111 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Manufacturer) · Lead Investigator: Thomas W. Halvorsen
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FDA Form 483 issued to Hillyard GMP (FEI 3009690111) on 2026-02-27 following an inspection of its drug manufacturer operations in Missouri. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.

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Observation-by-Observation 21 CFR Breakdown (3)

Observation #1 · 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 Hillyard GMP on 2026-02-27."
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 211.186(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 Hillyard GMP on 2026-02-27."
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 211.186(b)(9) Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
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 Hillyard GMP on 2026-02-27."
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.