Inspections and Audits

Pfizer’s Hospira Facility in India Hit With Lengthy 483

The FDA cited Pfizer’s Hospira manufacturing facility in Sriperumbudur, Tamil Nadu for a slew of repeat deficiencies, including falsifying data, in a Form 483 flagged as Official Action Indicated – indicating that the agency is planning further enforcement action against the company within six months. Read More

Chinese API Manufacturer Cited for Quality Shortcomings

The FDA issued a warning letter to Zhuhai United Laboratories, an active pharmaceutical ingredient firm based in Zhuhai, China, taking the facility to task for failure to investigate out-of-specification results and correct critical CGMP deviations. Read More