Form FDA 483 · Issued 2025-12-12
Dr. Reddy’s Laboratories Limited — FDA Form 483 Analysis
FEI: 3009193040 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Finished Pharmaceutical Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Dr. Reddy’s Laboratories Limited (FEI 3009193040) on 2025-12-12 following an inspection of its finished pharmaceutical manufacturer operations in India. The report documents 5 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 212.60(e)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Equipment
Inspector Observation Language: "All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results]. Specifically,observed during inspection of Dr. Reddy’s Laboratories Limited on 2025-12-12."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #2 · FDCA 505-1(f)(3)(B)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
Inspector Observation Language: "An application holder did not [ensure pharmacies that dispense the drug are specially certified] [ensure mechanisms are in place that allow pharmacies the ability to complete the certification process] [maintain a validated, secure database of certified pharmacies] [identify and address non-compliant certified pharmacies], as required by your approved REMS Element to Assure Safe Use (ETASU) B. Specifically, observed during inspection of Dr. Reddy’s Laboratories Limited on 2025-12-12."
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 #3 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Sporicidal agent, ISO 5/classified areas
Inspector Observation Language: "Use of a sporicidal agent in the facility's [ISO 5 areas] [classified areas] was [lacking] [improper] [infrequent]. Specifically, observed during inspection of Dr. Reddy’s Laboratories Limited on 2025-12-12."
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 #4 · FDCA 503B(a)(10)(B)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Drug product container, fails to include
Inspector Observation Language: "The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, observed during inspection of Dr. Reddy’s Laboratories Limited on 2025-12-12."
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 #5 · 21 CFR 211.67(b)(6)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Cleaning SOP/inspection
Inspector Observation Language: "Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, observed during inspection of Dr. Reddy’s Laboratories Limited on 2025-12-12."
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.