Calumet Karns City Refining LLC – FDA EIR, Aug 2, 2016

An FDA routine surveillance inspection of Calumet Penreco LLC in Karns City, PA, was conducted from August 1-2, 2016. This inspection focused on the company's manufacturing of bulk Active Pharmaceutical Ingredients (APIs), including USP and NF white oils and USP petrolatum, under the regulatory framework of FDA Compliance Program 7356.002F and FDA’s Q7A Good Manufacturing Practice Guidance for APIs. The inspection revealed several significant deficiencies. Key issues included the absence of written procedures for critical production and process controls, specifically a lack of complete manufacturing process validation for key steps like acid treatment and filtration for their API products, and an unvalidated antioxidant addition process. Furthermore, the company failed to establish or follow written procedures for the qualification (Installation, Operational, and Performance Qualification) of numerous GMP-critical manufacturing and testing equipment. There were also no established procedures for conducting annual product reviews for their APIs. A crucial observation was the inadequate testing and release of Petrolatum, USP, as not every batch was tested for antioxidant content, and no studies demonstrated the minimum antioxidant levels required for product stability. An FDA-483, detailing these Inspectional Observations, was issued to Plant Manager Mr. Lee Achensinski, who committed to providing a written response within 15 working days. The company was also advised to improve batch record details, develop a product matrix for stability testing of customized orders, consider establishing a Quality Assurance Department, and implement monitoring of audit trails for their Quality Control laboratory software. These actions are necessary to ensure compliance with good manufacturing practices.