FDA Hands Texas API Maker 12-Item Form 483

The FDA has slapped API maker ZS Pharma with a 12-observation Form 483, highlighted by lapses in data integrity, quality and cleanliness.

A March 2016 inspection found there were several instances at the Coppell, Texas-based facility of deleted files without any provided rationale, as well as unauthorized access to the computer system, according to the agency.

For example, a system administrator confirmed to the FDA that an individual from the R&D laboratory was accessing the firm’s XRD System without any records documenting the employee’s approved access or the level of access.