Inspections and Audits

Chinese Heparin Testing Lab Warned by FDA

A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Read More

Strides Gets 483 for Quality Problems

Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets. Read More

Ipca Products Banned From U.S. Market After Drug Shortage Ends

The FDA broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. The drugmaker’s continued GMP violations already kept most of the company’s products out of the U.S. market, but shortages led regulators to allow a handful of Ipca’s drugs into the country. Read More