Warning Letters Update

This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to establish prior notice. It communicates the agency's position on a matter, but it does not commit FDA to taking enforcement action. Basically, you should read Warning Letters relevant to your industry because they can provide you with examples of what not to do. Here’s a quick run-down of Warning Letters published this week that we thought merited a closer look:

  • FDA issued a March 31, 2015 Warning Letter to Hospira S.p.A. for alleged violations of current good manufacturing practice regulations (cGMP) for finished pharmaceuticals at a manufacturing plant in Italy. The Warning Letter provides that Hospira failed to:
    • establish procedures to prevent microbiological contamination of sterile drug products and include validation of sterilization processes;
    • thoroughly investigate any unexplained discrepancy or failure of any batch;
    • exercise appropriate controls over computer or related systems so that only authorized personnel institute changes in master production/controls records; and
    • ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

The Warning Letter details Hospira’s failure to evaluate certain airflow studies, and its improper rejection of various vials during the manufacturing process without explanation. Ultimately, FDA stated that Hospira’s response to its inspectional observations lacked adequate corrective action.

  • FDA issued March 27, 2015 Warning Letters respectively to Avanti Health Care and Kings Pharmacy regarding deficiencies in their practices for producing sterile drug products. Both firms compound drugs and registered with FDA as outsourcing facilities and, therefore, were required to, among other things, comply with the Compounding Quality Act and cGMP requirements. Though Avanti was cited for six (6) cGMP violations and Kings was cited for three (3), the letters are very similar in many respects. During the inspections of both facilities, respectively, FDA observed that, among many violations, drug products were prepared under insanitary conditions, where operators failed to use proper aseptic technique in designated areas. Both firms also failed to include mandatory labeling for compounded products (i.e., “this is a compounded drug” and “not for resale”). These letters demonstrate FDA’s ongoing effort to more closely regulate and inspect outsourcing facilities. Avanti registered as an outsourcing facility on April 21, 2014, and FDA began its inspection only two (2) months later on June 23; Kings Pharmacy registered on December 23, 2013, and was inspected just three (3) months later.
  • FDA issued a March 25, 2015 Warning Letter to Skin Authority, LLC for making promotional claims on its website that indicate that its products, though labeled as cosmetics, were, in fact, promoted as drugs. The Warning Letter lists examples of drug claims for serums, scrubs and creams made on the website, including, for example, “help inhibit cellular breakdown,” “foster skin growth,” “help counteract infection,” “improve anti-inflammatory response,” and “increase cell growth.” The products were not generally recognized as safe and effective for the uses listed on the website, were not subject to any FDA-approved New Drug Application, and, therefore, were “new drugs” that required FDA approval prior to marketing.

The information that the agency communicates in a Warning Letter can be invaluable as it provides important, cautionary lessons for regulated industry and provides a view into the agency’s current thinking. You can keep tabs on Warning Letters by checking our blog periodically or by looking on FDA’s Warning Letters webpage.

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