FDA WARNING_LETTER - Dr. Reddy's Laboratories Limited (Unit II) - March 06, 2015

The FDA issued a Warning Letter to Dr. Reddy's Laboratories Ltd. following inspections of three facilities in India (CTO Unit VI, CTO Unit V, and Unit-VII) between November 2014 and March 2015. The inspections revealed significant CGMP deviations for Active Pharmaceutical Ingredients (APIs) at CTO Units VI and V, and violations of CGMP regulations for finished pharmaceuticals (21 CFR Parts 210 and 211) at Unit-VII, rendering products adulterated. Key violations at CTO Unit VI included failure to maintain complete laboratory data (e.g., re-testing after failing results, undisclosed "Custom QC laboratory"), uncontrolled electronic data access, non-contemporaneous record-keeping, and inadequate document control. At CTO Unit V, deficiencies involved inadequate investigations into out-of-specification results, improper maintenance of quality-related documents, unauthorized data access for product release in SAP, and failure to identify intermediate storage containers. Unit-VII's violations, some recurrent, included failure to thoroughly investigate discrepancies (e.g., equipment malfunction during sterile filling), inadequate procedures to prevent microbiological contamination (media fill record issues), and insufficient written procedures for production and process controls (e.g., unacceptable visual inspection operator qualification). The FDA questioned the effectiveness of the corporate quality system due to recurrent and long-standing failures. Dr. Reddy's must provide a written response within 15 working days detailing corrective actions, supported by a third-party assessment of data integrity, root causes, and a global CAPA plan. Failure to comply may result in withheld approvals for new applications and refusal of product admission into the U.S.