FDA EIR - Conklin Company, Inc. - July 24, 2013

An FDA follow-up inspection was conducted at Conklin Company, Inc. in Shakopee, MN, from July 16 to July 24, 2013. This inspection aimed to verify the corrective actions implemented by the company following an October 2012 inspection, which had revealed significant Current Good Manufacturing Practice (cGMP) deficiencies for drug and dietary supplement products, alongside issues with misbranded dietary supplements, resulting in an eleven-item FDA-483. During this recent inspection, Conklin Company demonstrated substantial progress in addressing all previously identified violations. The company ceased production and destroyed its Fortress Defensive Skin Cream OTC drug product. They established new written procedures for verifying finished product specifications using third-party laboratories, managing customer complaints, defining probiotic product specifications, and governing product holding and distribution operations. Additionally, the company eliminated expiration dates, opting instead for manufacture dates, and outsourced all labeling operations to contract manufacturers. No new FDA-483 was issued during this inspection, signifying successful remediation of the prior deficiencies. However, three verbal recommendations were made and accepted by the company. These included enhancing procedures for finished product testing by detailing specific analyses and laboratories, clarifying timeframes and reporting responsibilities within the complaint handling process, and providing more specifics on product receipt, quarantine, release, and carrier details in the distribution procedures. This indicates the firm's commitment to compliance with regulatory standards.