FDA WARNING_LETTER - Staska Pharmaceuticals, Inc. - September 18, 2024

On May 5, 2025, the FDA issued a Warning Letter to Staska Pharmaceuticals, Inc. following an inspection from September 3-18, 2024. The inspection revealed that the facility's drug products failed to meet Section 503B of the FDCA conditions for outsourcing facilities and exhibited serious deficiencies in sterile drug production, posing patient risks.

Violations include: - **Failure to meet 503B conditions:** Compounding drugs using bulk substances from an unregistered establishment and inadequate labeling (missing adverse event reporting info, directions for use). This renders products ineligible for exemptions from drug approval, adequate directions for use, and Drug Supply Chain Security Act requirements. - **Adulterated Drug Products (Insanitary Conditions):** Aseptic operators reaching too far into ISO 5 hoods, media fills not under challenging conditions, and inadequate smoke studies. - **Adulterated Drug Products (CGMP Violations):** Failure to investigate discrepancies (21 CFR 211.192), inadequate written procedures for production/process control (21 CFR 211.100(a)), insufficient personnel training (21 CFR 211.25(a)), inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), improper equipment cleaning/maintenance (21 CFR 211.67(a)), and