FDA 483 - Frenda Corporation - August 01, 2022

Frenda Corporation, a drug manufacturer in Trujillo Alto, PR, was cited for severe deficiencies across its operations. The inspection revealed a complete lack of quality control, unvalidated water systems, inadequate raw material testing, and no stability program for its products. Furthermore, the facility was found to be unsanitary, infested with pests, and lacked basic written procedures for manufacturing and microbial control, indicating a fundamental failure to adhere to cGMP regulations.