PRIMROSE CANDY CO – FDA EIR, Dec 1, 2010

The FDA conducted a directed drug Current Good Manufacturing Practice (cGMP) inspection of Primrose Candy Co. in Chicago, IL, from November 1 to December 1, 2010. This inspection served as a follow-up to a previous one in 2009 that resulted in 26 identified deficiencies and a 'Voluntary Action Indicated' classification. The 2010 inspection, guided by Compliance Program 7356.002 for drug manufacturing and 7303.803 for domestic food safety, concentrated on the firm's corrective actions and a review of its Quality, Production, Laboratory, Facilities and Equipment, Materials, and Packaging and Labeling systems, particularly for drug products like cough drops. The inspection concluded with a 22-point FDA-483, Inspectional Observations, highlighting several persistent issues. Main violations included the continued failure to adequately verify the identity of drug components, maintain complete inventory and reconciliation records for materials, and perform crucial equipment qualification studies. The company also lacked written procedures for packaging and labeling issuance and reconciliation, had not conducted process validation studies for its drug products, and failed to establish written stability programs or data to support product expiration dates. These issues indicate non-compliance with drug cGMP regulations (e.g., 21 CFR 211). Management, including President and CEO Mark V. Puch, committed to addressing these observations and providing a written response.