Form FDA 483 · Issued 2026-01-19
Centrient Pharmaceuticals India Private Limited — FDA Form 483 Analysis
FEI: 3004497364 · Sector: Pharmaceuticals & Sterile/OTC Drugs (API Manufacturer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Centrient Pharmaceuticals India Private Limited (FEI 3004497364) on 2026-01-19 following an inspection of its api manufacturer operations in India. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.196
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Distribution Record Requirements
Inspector Observation Language: "Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product]. Specifically, observed during inspection of Centrient Pharmaceuticals India Private Limited on 2026-01-19."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #2 · 21 CFR 211.48(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Plumbing System Defects
Inspector Observation Language: "The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, observed during inspection of Centrient Pharmaceuticals India Private Limited on 2026-01-19."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.