Form FDA 483 · Issued 2025-11-27
Gland Chemicals Private Limited — FDA Form 483 Analysis
FEI: 3008386908 · Sector: EPA / Specialty Chemical (Producer of Regulated Products) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Gland Chemicals Private Limited (FEI 3008386908) on 2025-11-27 following an inspection of its producer of regulated products operations in India. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.42(c)(1)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Incoming material area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging. Specifically, observed during inspection of Gland Chemicals Private Limited on 2025-11-27."
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 211.42(c)(2)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Rejected Material Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition. Specifically,observed during inspection of Gland Chemicals Private Limited on 2025-11-27."
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.