Form FDA 483 · Issued 2025-09-19
Sun Pharmaceuticals Medicare Ltd. — FDA Form 483 Analysis
FEI: 3002957541 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Finished Pharmaceutical Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Sun Pharmaceuticals Medicare Ltd. (FEI 3002957541) on 2025-09-19 following an inspection of its finished pharmaceutical manufacturer operations in India. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.160(b)(1)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
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 Sun Pharmaceuticals Medicare Ltd. on 2025-09-19."
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 #2 · 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 Sun Pharmaceuticals Medicare Ltd. on 2025-09-19."
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 211.170(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 Sun Pharmaceuticals Medicare Ltd. on 2025-09-19."
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.