Items Tagged with 'Good Manufacturing Practice'

Manufacturers must react promptly or they risk getting a Warning Letter.

STAFFORD, TX—The FDA issued a warning to CooperSurgical after inspectors noted violations at the company’s assembly plant here.

EPSON’s new robot can withstand exposure to vapor-ized hydrogen peroxide gas.

WASHINGTON—The U.S. Food and Drug Administration has warned Zimmer Holdings Inc. about its practices for manufacturing and testing hip implants at an assembly plant in Puerto Rico.

LAKE FOREST, IL—Hospira Inc. has received a warning letter from the FDA stemming from an April inspection of the company’s medical device assembly plant in La Aurora de Heredia, Costa Rica.