Form FDA 483 · Issued 2026-05-15
Mylan Laboratories Limited — FDA Form 483 Analysis
FEI: 3005587313 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Finished Drug Product Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Mylan Laboratories Limited (FEI 3005587313) on 2026-05-15 following an inspection of its finished drug product manufacturer operations in India. The report documents 5 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
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 211.142(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
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 Mylan Laboratories Limited on 2026-05-15."
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 211.84(d)(2)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Component identification test
Inspector Observation Language: "Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis. Specifically, observed during inspection of Mylan Laboratories Limited on 2026-05-15."
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 #3 · 21 CFR 211.67(b)(3)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Cleaning SOPs/instructions
Inspector Observation Language: "Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance. Specifically, observed during inspection of Mylan Laboratories Limited on 2026-05-15."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #4 · 21 CFR 211.84(d)(2)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Component written specification
Inspector Observation Language: "Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, observed during inspection of Mylan Laboratories Limited on 2026-05-15."
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 211.56(a)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Sanitation--buildings not clean, free of infestation
Inspector Observation Language: "Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin]. Specifically, observed during inspection of Mylan Laboratories Limited on 2026-05-15."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.