FDA recently published a warning letter (dated June, 2011) to a virtual drug and device firm based in North Carolina, citing several quality concerns.  Chief among the issues raised by FDA was the firm’s failure to establish a quality agreement with the contract manufacturing organization (CMO) of one of its drug delivery devices, stating that “the responsibilities between [your firm] and the contractor have not been clearly defined.”

Inspectors also noted similar quality lapses with one of the company’s currently marketed drugs; however, the delivery device appears to have been FDA’s central focus, perhaps due to several (at least 12) complaints in recent years related to the device, ranging from manufacturing distortions and operating difficulties, to devices that simply don’t work.  FDA addressed the complaints by writing, “Our investigator observed correspondence from your contractor, attached to each complaint reviewed, indicating the need for device design changes.  Corrective and preventative measures have not been adequately addressed, documented, or implemented by your firm.”

The NC company quickly responded to the warning letter—the first and weakest in FDA’s arsenal of enforcement actions—with a comprehensive quality plan that was found to be acceptable by FDA.

The exchange highlights several quality control issues that Pearl Pathways’ clients must not only be cognizant of, but also be prepared to address in advance:

1. FDA takes quality agreements seriously. An article on Outsourcing-Pharma has quoted acting associate director of the FDA, Ann Meeker O’Connell, as saying, “A sponsor has to indicate what specific responsibilities they’re transferring [to a CRO] in writing.”
2. Responsibility for product quality lies with the firm.  Although the company’s response and overall quality plan were found to be acceptable, FDA still reminded the firm, “Your quality plan indicates that all product release testing will be conducted by your contractor.  It is our expectation that… as the owner of the device, which is labeled as marketed by your firm, you are ultimately responsible for… this product.”
3. Virtual companies are a matter of quality concern for FDA.  The warning letter also addressed the company’s failure to establish a quality plan for the firm itself, which is described by FDA as a virtual company.  The Agency stated, “Because the majority of your employees are located outside of the inspected corporate location, it is our expectation you will maintain quality policy training documentation that will be accessible during subsequent… inspections.”

To read the full warning letter, click here.  To read more about FDA’s quality systems regulation policies, click here.