FDA 483 - Aurobindo Pharma Ltd - May 24, 2019

This FDA Form 483 document details nine observations from an inspection conducted on May 14, 2019, at a pharmaceutical manufacturing facility.

**Observation 1:** The Quality Control Unit's responsibilities and procedures are not fully written or followed. The Quality Unit failed to assess conditions affecting manufacturing and QC tests. Uncontrolled, loose handwritten notebooks with lab data, a data logger temperature study, and unsigned SOPs for sterile operations were observed.

**Observation 2:** Active ingredient samples representative of each lot are not appropriately identified and retained. Physical retained sample weights for eleven API lots did not match electronic records in the LIMS system, raising concerns about the thoroughness of impurity testing for (b)(4) and (b)(4).

**Observation 3:** Written procedures for equipment cleaning and maintenance are not followed. Cleaning operations for a [REDACTED] (tablet press) and its room did not align with SOP FU3-PR-MF-CLN-072. Observed cleaning times varied significantly from logbook entries and validation/verification studies. Operators failed to perform specific cleaning steps, including wiping surfaces with disinfectant and using a vacuum cleaner, and incorrectly marked a checklist.

**Observation 4:** Laboratory records lack complete data. The firm's data integrity program is inadequate, with no sufficient review of electronic raw data by the Quality Unit. The system administrator and QA administrator have privileges to "Verify Incomplete Data in Raw Data Files"