Form FDA 483 · Issued 2026-02-17
BeOne Medicines USA, Inc. — FDA Form 483 Analysis
FEI: 3028672933 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Regulated Products) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to BeOne Medicines USA, Inc. (FEI 3028672933) on 2026-02-17 following an inspection of its producer of regulated products operations in New Jersey. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.165(c)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Sampling and testing plans not followed
Inspector Observation Language: "Written procedures for sampling and testing plans are not followed for each drug product. Specifically, observed during inspection of BeOne Medicines USA, Inc. on 2026-02-17."
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 211.188(b)(1)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Dates not included for each significant step
Inspector Observation Language: "Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced. Specifically, observed during inspection of BeOne Medicines USA, Inc. on 2026-02-17."
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 #3 · 21 CFR 314.80(d)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Failure to submit scientific article
Inspector Observation Language: "A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy of the published article. Specifically, observed during inspection of BeOne Medicines USA, Inc. on 2026-02-17."
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 · 21 CFR 212.60(c)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Analytical methods
Inspector Observation Language: "Your laboratory analytical methods are not [suitable for their intended use] [sufficiently sensitive] [sufficiently specific] [sufficiently accurate] [sufficiently reproducible]. Specifically, observed during inspection of BeOne Medicines USA, Inc. on 2026-02-17."
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 212.110(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Record quality
Inspector Observation Language: "All records including those not stored at your inspected establishment are not [legible] [stored to prevent deterioration or loss] [readily available for review and copying by FDA employees]. Specifically,observed during inspection of BeOne Medicines USA, Inc. on 2026-02-17."
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.