Valeant hit with FDA warning letter for CMO oversight shortcomings

Valeant Pharmaceuticals ($VRX) has grown quickly over the past few years as it has pursued, bought and divested pharmaceutical assets. But somewhere along the way oversight of a supplier slipped. The FDA spotted the problems during a recent visit to Valeant's U.S. headquarters, leading to the posting of a warning letter.

The warning letter highlights some areas that FDA inspectors were dissatisfied with, in Valeant's management of the contract manufacturer that supplied it with Sculptra Aesthetic. In particular, inspectors noted two times that the manufacturer stopped the production process to fix problems that were affecting drug quality. Someone from the quality assurance team at Valeant should have reviewed and approved the vendor's deviation report, but the FDA found no evidence this had happened.

Inspectors also took Valeant to task for failing to audit a supplier, but were satisfied by the company's response to this failure. The FDA was less impressed by Valeant's response to inspectors' observation that the company had failed to monitor the effectiveness of a Corrective and Preventive Action (CAPA). The regulator wants to see evidence Valeant has taken steps to improve its monitoring of CAPAs and review of supplier deviation reports.

Valeant is confident it can resolve issues raised in the warning letter in a "timely manner." And the potential impact on its business is limited as Valeant has already divested Sculptra Aesthetic as part of its $1.4 billion deal with Nestle's Galderma unit.

- read the warning letter
- check out Pharmalot's take
- here's Valeant's press release
- and here's FiercePharma's take