FDA EIR - Nephron Sterile Compounding Center LLC - April 21, 2017

An FDA inspection of Nephron Pharmaceuticals Corporation (also known as Nephron Outsourcing Facility), located in West Columbia, SC, was conducted from April 17 to April 21, 2017. This high-priority inspection focused on assessing the firm's adherence to minimum standards for producing compounded sterile products, evaluating compliance with Section 503B requirements, and ensuring patient safety under the FD&C Act and 21 CFR 211 Good Manufacturing Practices. The inspection revealed several significant deficiencies documented on an FDA Form-483. Key issues included the lack of aseptic process validation for phenylephrine hydrochloride production, inadequate training for visual inspection personnel (using vials instead of syringes, and absence of a defect library), and failure to implement required Supplier Quality Agreements with certain critical suppliers. Additionally, some product labels were missing the firm's address and/or phone number. Verbal discussions with management also highlighted the need for labeling consistency, improved endotoxin reporting, inclusion of formula worksheets in batch records, and larger sample sizes for endotoxin testing. Management acknowledged the observations and indicated that many deficiencies were already being addressed or would be corrected within 15 business days of receiving the FDA Form-483. The company committed to providing documentation of these corrective actions. This inspection aimed to mitigate risks associated with compounded sterile drug production and reinforce regulatory compliance.