Mark K. Taylor
CEO and Pharmacist-in-Charge
Curexa – East, LLC dba Curexa
3007 Ocean Heights Avenue
Egg Harbor Township , NJ 08234-7749
United States
mtaylor@curexa.comFEI 3011761882Issued Sep 13, 2023Office of Pharmaceutical Quality
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 3011761882.
Violations3
Issue DateSep 13, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Curexa – East, LLC dba Curexa
Location
Mark K. Taylor
CEO and Pharmacist-in-Charge
Curexa – East, LLC dba Curexa
3007 Ocean Heights Avenue
Egg Harbor Township , NJ 08234-7749
United States
mtaylor@curexa.com
FEI Number
3011761882
Country
United States
Issue Date
September 13, 2023
Issuing Office
Office of Pharmaceutical Quality
Product Type
Drugs
Status
Open
Summary
Curexa – East, LLC, a compounding pharmacy in New Jersey, produced adulterated drug products in violation of federal law during an FDA inspection conducted August-September 2022. FDA investigators documented serious deficiencies including non-microbial contamination in production areas and inadequate cleaning of utensils, components, and containers when manufacturing hazardous drugs, which created risk of cross-contamination and rendered products potentially injurious to health. The facility's practices failed to meet current good manufacturing practice (CGMP) standards required under Section 503A of the Federal Food, Drug, and Cosmetic Act, despite the company's October 2022 response to the inspection findings.
Curexa – East, LLC dba Curexa FDA Warning Letter, September 13, 2023