Form FDA 483 · Issued 2025-10-17
Alps Pharmaceutical Industrial Co., Ltd. — FDA Form 483 Analysis
FEI: 3002806352 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Active Pharmaceutical Ingredient Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Alps Pharmaceutical Industrial Co., Ltd. (FEI 3002806352) on 2025-10-17 following an inspection of its active pharmaceutical ingredient manufacturer operations in Japan. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 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 Alps Pharmaceutical Industrial Co., Ltd. on 2025-10-17."
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 211.48(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Drains--Size, Back-siphonage Prevention
Inspector Observation Language: "Drains are not [of adequate size] [provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer]. Specifically, observed during inspection of Alps Pharmaceutical Industrial Co., Ltd. on 2025-10-17."
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 #3 · 21 CFR 211.160(b)(1)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Retesting
Inspector Observation Language: "The specifications for [components] [drug product containers] [closure] are deficient in that they do not include appropriate retesting requirements. Specifically, observed during inspection of Alps Pharmaceutical Industrial Co., Ltd. on 2025-10-17."
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 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Written calibration procedures
Inspector Observation Language: "Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for remedial action if limits are not met]. Specifically, observed during inspection of Alps Pharmaceutical Industrial Co., Ltd. on 2025-10-17."
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 211.170(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Reserve sample quantity - active ingredients only
Inspector Observation Language: "The reserve sample of active ingredient does not consist of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications. Specifically, observed during inspection of Alps Pharmaceutical Industrial Co., Ltd. on 2025-10-17."
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.