Valeant Pharmaceuticals International, Inc – FDA Warning Letter, Jun 26, 2014

On June 26, 2014, the FDA issued a Warning Letter to Valeant Pharmaceuticals International following an inspection from June 13-26, 2014. The inspection revealed that their Sculptra Aesthetic injectable poly-L-Lactic acid product is an adulterated device under section 501(h) of the Act, as its manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The violations include: 1. **Failure to establish and maintain procedures for nonconforming product disposition (21 CFR 820.90(b)(1))**: Valeant failed to implement procedure GMS-143, which requires their QA/Design Control Center to review and approve deviation investigation reports from third-party suppliers. Examples cited include unreviewed deviation reports for Sculptra batches A3063 and A3066, which involved manufacturing nonconformities like defective equipment and pressure issues during sterilization. The firm's responses were deemed inadequate as no evidence was provided to demonstrate control over the review and disposition process. 2. **Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a))**: Valeant failed to implement procedure GMS