Form FDA 483 · Issued 2026-02-20
Maiva Pharma Private Limited — FDA Form 483 Analysis
FEI: 3014362214 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Maiva Pharma Private Limited (FEI 3014362214) on 2026-02-20 following an inspection of its sterile drug manufacturer operations in India. The report documents 5 inspection observations centered on Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems, Label Control, Undeclared Allergens & Structure/Function Claims.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 5 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Backup file not maintained
Inspector Observation Language: "Failure to maintain a backup file of data entered into the computer or related system. Specifically, observed during inspection of Maiva Pharma Private Limited on 2026-02-20."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.
Observation #2 · 21 CFR 211.122(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Written procedures describing in detail
Inspector Observation Language: "There is a lack of written procedures describing in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of labeling and packaging materials. Specifically, observed during inspection of Maiva Pharma Private Limited on 2026-02-20."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #3 · 21 CFR 211.167(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Controlled release dosage form testing
Inspector Observation Language: "Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient. Specifically, observed during inspection of Maiva Pharma Private Limited on 2026-02-20."
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 #4 · 21 CFR 211.65(a)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Equipment construction - reactive surfaces
Inspector Observation Language: "Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. Specifically, observed during inspection of Maiva Pharma Private Limited on 2026-02-20."
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.
Observation #5 · 21 CFR 211.165(c)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Sampling and testing plans not followed
Inspector Observation Language: "Written procedures for sampling and testing plans are not followed for each drug product. Specifically, observed during inspection of Maiva Pharma Private Limited on 2026-02-20."
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.