FDA 483 - BRENNTAG PACIFIC, INC. - May 06, 2021

BRENNTAG PACIFIC, INC. in Santa Fe Springs, CA, a manufacturer/repacker/relabeller, was inspected by the FDA from April 29 to May 6, 2021. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of written procedures for responsibilities and inadequate employee training for drug product testing. Additionally, the firm failed to establish written procedures for production and process controls, including deviation and Out-Of-Specification investigations.