Form FDA 483 · Issued 2026-03-20
Abbisko Therapeutics Co., Ltd. — FDA Form 483 Analysis
FEI: 3020982471 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Regulated Products) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Abbisko Therapeutics Co., Ltd. (FEI 3020982471) on 2026-03-20 following an inspection of its producer of regulated products operations in China. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 3 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.166(a)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Testing in same container - closure system
Inspector Observation Language: "The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed. Specifically, observed during inspection of Abbisko Therapeutics Co., Ltd. on 2026-03-20."
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 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Calibration - at intervals, written program, remedial action
Inspector Observation Language: "The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met]. Specifically, observed during inspection of Abbisko Therapeutics Co., Ltd. on 2026-03-20."
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 211.67(c)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Cleaning/maintenance records not kept
Inspector Observation Language: "Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, observed during inspection of Abbisko Therapeutics Co., Ltd. on 2026-03-20."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.