FDA Answers on 14-months-delayed Warning Letter
With apologies for missing our deadline on last week’s report about a Warning Letter that took almost 14 months to be issued to Myerlee Pharmacy, Fort Myers, FL, FDA’s Office of Media Affairs 2/29 obliquely provided an indirect explanation that accepted no responsibility for the shock the agency’s delay caused the pharmacy. Indeed, beyond saying “it takes time to review the evidence,” the response did not address specifics of the review in this case that caused so much time to elapse between the inspection and the issuance of the Warning Letter. Warning Letters, it said, are FDA’s “principal means of achieving prompt voluntary compliance.”
As we reported, Myerlee’s prompt voluntary compliance occurred without the spur of a Warning Letter.
The agency also answered a second question about why it routinely posts FDA-483s to compounding pharmacies on its Web site but not FDA-483s issued to other inspected entities. Here is FDA’s response in full:
“While the FDA works to promptly review each case, we have conducted more than 230 inspections since the Drug Quality and Security Act was enacted (November 2013). It takes time to review the evidence in each of these cases and determine the appropriate action, if any, to protect public health. The FDA’s focus is on protecting the public health. When we uncover serious violations of federal law that present an immediate risk to the public health, we will continue to take action as appropriate.
“Warning letters are issued to achieve voluntary compliance and to establish prior notice to a firm in the event that an enforcement action becomes necessary. The use of warning letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law when violations are identified. A warning letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act.
“The FDA makes 483s publicly available either proactively at our discretion, or because they are frequently requested (see the Electronic Freedom of Information Act Amendments of 1996). The agency has been posting all 483s issued to compounding pharmacies proactively to share the problems FDA is identifying at compounding facilities in the wake of the fungal meningitis outbreak so that others can learn from the observations and hopefully correct problems at their own facilities before someone is harmed by a drug compounded under poor conditions. In addition, information about inspections at compounding pharmacies is frequently requested by states and other stakeholders.
“For the Myerlee inspection, our records indicate that the inspection was initiated on December 1, 2014, and was closed on December 22, 2014. The investigators were actually in the firm on the following days: December 1, 2, 3, 4, 5, and 22, 2014. The Form FDA 483 was issued to the firm at the close of the inspection on December 22, 2014, and accurately reflects the dates during which the inspection was open (December 1, 2014 – December 22, 2014).”
(FDA Webview had questioned an apparent discrepancy between the five days of the inspection reported to us by the pharmacy’s owners, and the 21-day extent of it shown on the FDA-483.)