Inspections and Audits

FDA Issues First Required Inspections Report, Covering 2017

In its first required inspection metrics report for 2017, FDA officials found a median time of 102 days between inspection requests by the FDA to a facility and the beginning of inspections, and a median of seven days between the beginning of a pre-approval inspection and the issuance of a Form 483. Read More

Tris Pharma Slammed for Adulterated Products

The FDA warned Tris Pharma for manufacturing adulterated products at its Monmouth Junction, New Jersey facility, citing failures to properly investigate product defects and other deficiencies found during a March inspection. Read More