FDA 483 - Dr. Reddy's Laboratories Ltd. - June 21, 2019

This FDA Form 483 document details observations from an inspection concerning the manufacturing of (b)(4) Injection (b)(4) mg/4 mL.

Observation 1 notes that acceptance criteria were not established prior to validation activities. Specifically, the firm's determination of acceptance criteria for (b)(4) Functionality Testing (Break loose force & Glide force) for finished product release was unclear. While data from stability studies for (b)(4) samples (Batches: (b)(4)) provided reference data for Break loose force of (b)(4) Newton and Glide force of (b)(4) Newton, the established finished product release specification test limits were (b)(4) Newton for Break loose force and (b)(4) Newton for Glide force. These limits lacked scientific data to support their impact on the end user or finished product functionality.

Observation 2 states that the device design was not correctly translated into production specifications. The firm's Acceptance Quality Limit (AQL) did not account for critical dimension specifications of components like (b)(4) and stoppers during their receipt for the manufacture of (b)(4) Injection (b)(4) mg/4 mL.

The firm promised to correct both Observation 1 and Observation 2.