Form FDA 483 · Issued 2025-11-14
Asahi Kasei Finechem Co., Ltd. — FDA Form 483 Analysis
FEI: 3002806404 · Sector: Pharmaceuticals & Sterile/OTC Drugs (API (animal origin) Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Asahi Kasei Finechem Co., Ltd. (FEI 3002806404) on 2025-11-14 following an inspection of its api (animal origin) manufacturer operations in Japan. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 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 Asahi Kasei Finechem Co., Ltd. on 2025-11-14."
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 #2 · 21 CFR 211.180(e)(1)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Representative Number of Batches for Annual Review
Inspector Observation Language: "The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of [approved] [rejected] batches. Specifically, observed during inspection of Asahi Kasei Finechem Co., Ltd. on 2025-11-14."
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 211.184(c)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Individual inventory record
Inspector Observation Language: "Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associated batch or lot of drug product. Specifically, observed during inspection of Asahi Kasei Finechem Co., Ltd. on 2025-11-14."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #4 · 21 CFR 211.188(b)(13)
Master Manufacturing & Batch Production Records (MMR/BPR)
REPEAT CITATION AT FACILITY
Results of drug product inspections and examinations
Inspector Observation Language: "The batch production and control records are deficient in that they do not include results of drug product [examinations] [inspections]. Specifically, observed during inspection of Asahi Kasei Finechem Co., Ltd. on 2025-11-14."
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 #5 · 21 CFR 211.194(a)(8)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Identification of Person Performing Review of Lab Records
Inspector Observation Language: "Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy. Specifically, observed during inspection of Asahi Kasei Finechem Co., Ltd. on 2025-11-14."
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.