American Specialty Pharmacy, Inc. dba ASP Cares

Warning LetterOpen

Abdul Hameed President/Owner American Specialty Pharmacy, Inc. dba ASP Cares 13988 Diplomat Drive, Ste 100 Farmers Branch , TX 75234-8807 United States ahameed@aspcares.comFEI 3011677351Issued Apr 5, 2021Office of Pharmaceutical Quality Operations, Division II

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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 3011677351.

Violations7

Issue DateApr 5, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: American Specialty Pharmacy, Inc. dba ASP Cares
Location: Abdul Hameed President/Owner American Specialty Pharmacy, Inc. dba ASP Cares 13988 Diplomat Drive, Ste 100 Farmers Branch , TX 75234-8807 United States ahameed@aspcares.com
FEI Number: 3011677351
Country: United States
Issue Date: April 05, 2021
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Drugs
Status: Open

Summary

American Specialty Pharmacy, Inc. dba ASP Cares, a registered outsourcing facility, produced sterile compounded drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) to qualify for exemptions from drug approval and labeling requirements. During an FDA inspection conducted August 14-23, 2018, investigators identified serious deficiencies in the facility's practices for producing sterile drug products that put patients at risk and violated FDCA requirements. The company's responses to an FDA Form 483 and subsequent information request in 2018-2019 were insufficient to resolve the documented compliance failures.

American Specialty Pharmacy, Inc. dba ASP Cares FDA Warning Letter, April 5, 2021