Stokes Healthcare Inc. dba Epicur Pharma

Warning LetterOpen

Michael Tursi CEO Stokes Healthcare Inc. dba Epicur Pharma 8000 Commerce Parkway, Suite 600 Mount Laurel , NJ 08054-2211 United States mtursi@stokespharmacy.comFEI 3002815949Issued Apr 2, 2024Division of Pharmaceutical Quality Operations I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002815949.

Violations12

Issue DateApr 2, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Stokes Healthcare Inc. dba Epicur Pharma
Location: Michael Tursi CEO Stokes Healthcare Inc. dba Epicur Pharma 8000 Commerce Parkway, Suite 600 Mount Laurel , NJ 08054-2211 United States mtursi@stokespharmacy.com
FEI Number: 3002815949
Country: United States
Issue Date: April 02, 2024
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Stokes Healthcare Inc. dba Epicur Pharma, an outsourcing facility registered to compound sterile drugs under FDA section 503B, produced adulterated drug products that failed to meet the conditions required for compounding exemptions from drug approval requirements. During a September-October 2023 inspection, FDA investigators identified serious deficiencies in the company's practices for producing sterile drug products that put patients at risk and determined the facility's products violated the Federal Food, Drug, and Cosmetic Act. The company received a Form FDA 483 on October 25, 2023, and submitted a response on November 15, 2023, but the violations were significant enough to warrant the warning letter issued April 2, 2024.

Stokes Healthcare Inc. dba Epicur Pharma FDA Warning Letter, April 2, 2024