FDA WARNING_LETTER - FSC Laboratories, Inc. - March 17, 2011

On March 14-17, 2011, an FDA inspection of FSC Laboratories, Inc. (FSC) in Charlotte, NC, identified that their E-Z Spacer inhalation device, for which FSC holds a 510(k) application, was adulterated. The device's manufacture, packing, storage, or installation methods, facilities, or controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to establish procedures for and conduct management reviews of the quality system (21 CFR Part 820.20(c)). While FSC's response was deemed adequate, the management review agenda did not include discussions of new product introductions requiring quality system revisions, despite their SOP. 2. Failure of management to establish and communicate a quality policy (21 CFR 820.20(a)). FSC's response was adequate, but documentation of quality policy training for all employees, especially those off-site, was not explicitly addressed. 3. Failure to establish a quality plan defining practices, resources, and activities for devices, specifically lacking a quality agreement with the E-Z Spacer contract manufacturer, and also for a drug product (b)(4) (21 CFR 820.20(d)). FSC's response was adequate,