Form FDA 483 · Issued 2025-12-11
SNJ Labs Private Ltd. — FDA Form 483 Analysis
FEI: 3026587575 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to MSN Laboratories Private Limited (FEI 3026587575) on 2025-12-11 following an inspection of its sterile manufacturer operations in India. The report documents 2 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 2 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · FDCA 501(a)(2)(A)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Non-sterile disinfecting agents, ISO 5 area/classified areas
Inspector Observation Language: "Use of non-sterile [disinfecting agents] [cleaning pads] [cleaning wipes] in the [ISO 5 area] [classified areas]. Specifically, observed during inspection of MSN Laboratories Private Limited on 2025-12-11."
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 #2 · FDCA 503B(b)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
All inclusive product report, not submitted
Inspector Observation Language: "Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, observed during inspection of MSN Laboratories Private Limited on 2025-12-11."
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.