Form FDA 483 · Issued 2026-04-24
Zhejiang Huahai Pharmaceutical Co., Ltd. — FDA Form 483 Analysis
FEI: 3003999190 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Manufacturer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Zhejiang Huahai Pharmaceutical Co., Ltd. (FEI 3003999190) on 2026-04-24 following an inspection of its drug manufacturer operations in China. The report documents 2 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.180(e)(2)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
REPEAT CITATION AT FACILITY
Items to cover on annual reviews
Inspector Observation Language: "Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product]. Specifically, observed during inspection of Zhejiang Huahai Pharmaceutical Co., Ltd. on 2026-04-24."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #2 · 21 CFR 211.180(e)(1)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Review of representative number of batches
Inspector Observation Language: "Written procedures are not [established] [followed] for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. Specifically, observed during inspection of Zhejiang Huahai Pharmaceutical Co., Ltd. on 2026-04-24."
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.