FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

DA Raps Ipca Laboratories’ Quality Unit for ‘Cascade of Failure’

Sept. 20, 2019
A A

Numerous quality failures and other violations earned Ipca Laboratories’ western India facility a Form 483 following an inspection last month.

The investigators found “a cascade of failure” in the quality unit for the issuance of GMP forms, reviewing lab testing data, conducting investigations and following written procedures.

The company also left multiple complaint investigations open for long periods. In one case, an investigation into a complaint of hair found in a product was left open for over five months despite having four previous extensions.

View today's stories