In the letter the US Food and Drug Administration (FDA) criticises FSC, described by the Agency as a virtual company, for its failure to form a quality agreement with the manufacturer of its drug delivery device.
“Your firm has not established a quality agreement with the contract manufacturer of the EZ Spacer nebulizer devices. The responsibilities between FCS and the contractor have not been clearly defined”, the FDA wrote in a warning letter, dated June but published this week.
Inspectors made a similar observation about the lack of a quality agreement between FSC and its contract manufacturer for an unnamed drug. FSC has sent a response to the FDA and, while finding the overall quality plan adequate, the Agency raises points the company must consider.
“Your quality plan indicates that all product release testing will be conducted by your contactor. It is our expectation that you are aware that as the owner of the device, which is labelled as marketed by your firm, you are ultimately responsible for…this product”, the FDA wrote.
Quality agreements are important to the FDA. Speaking about CROs (contract research organisations) last year, Ann Meeker O’Connell, acting associate director at the FDA, told Outsourcing-Pharma: “A sponsor has to indicate what specific responsibilities they’re transferring…in writing.”
The lack of a quality agreement was highlighted by problems with EZ Spacer devices. Since 2008 FSC has received at least 12 complaints for distorted handles, opening difficulties, and broken devices.
“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 FDA wrote.
FSC also failed to create a quality policy for the firm or communicate it to staff. The virtual-model used by FSC, with most employees based outside the inspected site, creates further quality topics to consider.
As with most of the points raised in the warning letter, the FDA said FSC’s response to this problem is adequate but there are still potential pitfalls. In this case the FDA is concerned about the lack of wording to explicitly indicate whether FSC will document the policy in each employee’s training file.
“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 FDA establishment inspections”, the Agency wrote.