Form FDA 483 · Issued 2026-05-01
Alkem Laboratories Limited — FDA Form 483 Analysis
FEI: 3006370524 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Finished Drug Product Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Alkem Laboratories Limited (FEI 3006370524) on 2026-05-01 following an inspection of its finished drug product manufacturer operations in India. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.84(d)(2)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Establish reliability of supplier's C of A
Inspector Observation Language: "Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals. Specifically, observed during inspection of Alkem Laboratories Limited on 2026-05-01."
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 211.180(e)(2)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Items to cover on annual reviews
Inspector Observation Language: "Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product]. Specifically, observed during inspection of Alkem Laboratories Limited on 2026-05-01."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #3 · 21 CFR 211.180(e)(1)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Review of representative number of batches
Inspector Observation Language: "Written procedures are not [established] [followed] for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. Specifically, observed during inspection of Alkem Laboratories Limited on 2026-05-01."
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.