trending Market Intelligence /marketintelligence/en/news-insights/trending/pqJTbId8GYYgvt3TPN0CKg2 content esgSubNav
In This List

Dr. Reddy's manufacturing facility flagged by US FDA for potential violations

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Dr. Reddy's manufacturing facility flagged by US FDA for potential violations

The U.S. Food and Drug Administration issued a Form 483 with eight observations about Dr. Reddy's Laboratories Ltd.'s manufacturing plant in Andhra Pradesh, India.

The U.S. regulator issues this form to companies to list violations observed during an inspection. Among the violations, the inspector noted that the quality control unit at Dr. Reddy's facility lacked authority to fully investigate errors that have occurred.

Additionally, the sterilization procedures to prevent microbiological contamination in the facility were not valid. The inspection also unearthed a quality deficiency in the filtered air supply and equipment to control air pressure, micro-organisms, dust, humidity and temperature.

The FDA observed that Dr. Reddy's could not justify deviations from production and process control procedures. Moreover, there were no control procedures to validate manufacturing processes that could cause variations in the characteristics of the drug produced.