Nephron SC Inc. — FDA Warning Letter Findings

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm failed to conduct adequate and timely investigations relating to products made by both terminal sterilization and aseptic processing. Cross Contamination Your firm manufactures products that undergo moist heat sterilization, including Sterile…

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). Sampling of the BFS machines in your EM program for ISO 5 active air viable and non-viable monitoring is deficient. You failed to demonstrate that the method used for sample collection for EM (e.g., use of tubing with a length of about (b)(4) and material) provides a meaningful and representative sample of conditions during…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). You did not establish appropriate environmental monitoring (EM) action levels for the ISO 5 critical area where drugs are most vulnerable to contamination. Samples from the ISO 5 critical area should normally…