Form FDA 483 · Issued 2026-02-09
Biomylz Private Limited — FDA Form 483 Analysis
FEI: 3013697420 · Sector: Pharmaceuticals & Sterile/OTC Drugs (OTC Drug Manufacturer) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Biomylz Private Limited (FEI 3013697420) on 2026-02-09 following an inspection of its otc drug manufacturer operations in India. The report documents 4 inspection observations centered on Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · FDCA 501(a)(2)(A)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Lack of disinfection, equipment/supplies from lower to higher quality air
Inspector Observation Language: "Lack of disinfection of [equipment] [supplies] at each transition from areas of lower quality air to areas of higher quality air. Specifically, observed during inspection of Biomylz Private Limited on 2026-02-09."
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 211.42(c)(9)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Control / Lab Operations Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations. Specifically, observed during inspection of Biomylz Private Limited on 2026-02-09."
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 211.125(f)
Label Control, Undeclared Allergens & Structure/Function Claims
REPEAT CITATION AT FACILITY
Procedures Written and Followed
Inspector Observation Language: "Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, observed during inspection of Biomylz Private Limited on 2026-02-09."
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 #4 · 21 CFR 211.84(d)(6)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Objectionable microbiological contamination
Inspector Observation Language: "Each lot of a [component] [drug product containers] [closures] liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use. Specifically, observed during inspection of Biomylz Private Limited on 2026-02-09."
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.