Form FDA 483 · Issued 2025-11-21
HEC Pharm Co. Ltd. — FDA Form 483 Analysis
FEI: 3006259537 · Sector: Pharmaceuticals & Sterile/OTC Drugs (API Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to HEC Pharm Co. Ltd. (FEI 3006259537) on 2025-11-21 following an inspection of its api manufacturer operations in China. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.130(d)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Examination of packaging and labeling
Inspector Observation Language: "Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records]. Specifically, observed during inspection of HEC Pharm Co. Ltd. on 2025-11-21."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #2 · 21 CFR 211.137(b)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Storage conditions
Inspector Observation Language: "Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies. Specifically, observed during inspection of HEC Pharm Co. Ltd. on 2025-11-21."
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 211.94(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Protection from external factors
Inspector Observation Language: "Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. Specifically, observed during inspection of HEC Pharm Co. Ltd. on 2025-11-21."
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.