Staska Pharmaceuticals, Inc.

Warning LetterOpen

United StatesIssued May 5, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateMay 5, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Staska Pharmaceuticals, Inc.
Location: United States
FEI Number: N/A
Country: United States
Issue Date: May 05, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Staska Pharmaceuticals, Inc., an outsourcing facility registered to compound sterile drugs, produced drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act and violated federal regulations. During a September 2024 inspection, FDA investigators identified serious deficiencies in the company's practices for producing sterile drug products that put patients at risk, including a voluntary recall initiated in September 2024 for Ascorbic Acid Solution for Injection due to glass particulates. The facility's compounded drugs did not qualify for exemptions from drug approval requirements because they failed to comply with applicable FDCA provisions governing outsourcing facilities.

Staska Pharmaceuticals, Inc. FDA Warning Letter, May 5, 2025