Delta Pharma, Inc. – FDA Warning Letter, Oct 2, 2013

The FDA issued Warning Letter 2015-NOL-04 to Delta Pharma, Inc. following a September-October 2013 inspection prompted by adverse event reports from patients receiving their Deltalone-40. The inspection revealed serious deficiencies in sterile drug production, posing patient risks.

Key violations include: - Use of non-sterile disinfectants in the clean room and failure to disinfect equipment/materials before introduction into the ISO 5 area. - Inadequate clean room design and operation, specifically insufficient differential pressure, allowing lower quality air influx from the gowning room. - Failure to demonstrate adequate protection of the ISO 5 area by the hood. - Production of unapproved new drugs and misbranded products due to lack of valid prescriptions for individually-identified patients prior to distribution. - Insanitary conditions causing sterile drug products to be adulterated under Section 501(a)(2)(A) of the Act. - Significant Current Good Manufacturing Practice (CGMP) violations, including: - Failure to establish and follow written procedures to prevent microbiological contamination and validate aseptic/sterilization processes (21 CFR 211.113(b)). - Failure to establish an adequate environmental monitoring system in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). - Deficient air supply in aseptic processing areas (21 CFR 21