FDA EIR - Virchow Laboratories Ltd. - December 11, 2015

An FDA inspection of Virchow Laboratories Ltd., an active pharmaceutical ingredient manufacturer located in Hyderabad, India, took place from December 7 to December 11, 2015. The inspection, conducted under Compliance Program 7356.002F and guided by Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (Q7A), covered quality, facilities, equipment, material systems, production, and laboratory controls.

The inspection resulted in four significant observations documented on an FDA Form 483. Main issues included: 1) The absence of written responsibilities for personnel, especially contract employees involved in cGMP functions, and a lack of corresponding training records. 2) Inadequate standard operating procedures to prevent product mix-ups, particularly for different grades of API, due to insufficient unique identification on product labels. 3) Failure to consistently follow written procedures for documenting sample loading events in stability chambers. 4) Master Production Instructions that lacked detailed, specific ranges for critical process parameters during API manufacturing.

Mr. M. Narayana Reddy, the Managing Director, acknowledged the observations and committed to submitting a written response to the FDA within 15 working days, agreeing to address the identified deficiencies.