Form FDA 483 · Issued 2026-05-20
Strides Pharma Science Limited — FDA Form 483 Analysis
FEI: 3004554612 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Human Drug Manufacturer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Strides Pharma Science Limited (FEI 3004554612) on 2026-05-20 following an inspection of its human drug manufacturer operations in India. The report documents 2 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.100(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
SOPs not followed / documented
Inspector Observation Language: "Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, observed during inspection of Strides Pharma Science Limited on 2026-05-20."
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 #2 · 21 CFR 211.142(b)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Storage under appropriate conditions
Inspector Observation Language: "Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected. Specifically, observed during inspection of Strides Pharma Science Limited on 2026-05-20."
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.