FDA Warns American Specialty Pharmacy for Adulteration

The FDA warned drug product manufacturer American Specialty Pharmacy over adulteration at its Dallas, Texas facility.

FDA officials inspected the facility in 2015 and issued a Form 483, but the company’s inadequate responses to the agency’s observations prompted the warning letter.

The inspectors found that products were manufactured, packed or held in unsanitary conditions, that employees used expired cleaning products, and the firm had not conducted environmental monitoring within one of its cleanroom areas since January 2015.

In response to the Form 483, American Specialty said it would close the facility’s sterile drug division. In the warning letter, the agency says if the firm decides to resume production, it needs to hire a third-party consultant to help assess its facility design, personnel, systems and procedures.