FDA Issues Warning Letter to Drug Compounder

July 23, 2015

FDA warns an Arkansas compounding company that it is in violation of the FDCA.

 

An FDA warning letter, dated June 25, was issued to SCA Pharmaceuticals of Little Rock, Arkansas, stating that the company is producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA). The warning comes after the agency inspected the Little Rock facility from March 17–April 1, 2014, which resulted in a FDA 483.

During the FDA inspection, investigators found deficiencies in the company’s production of sterile drug products, including failure to adequately perform investigations of sterility failures and batches of product that contained particulates.  FDA also noted the company had not met the necessary conditions of section 503B of the FDCA in order to be exempt from certain requirements. FDA listed the following violations in the warning letter:

  • Drug products that did not include label statements, such as, “This is a compounded drug,” “Not for resale,” and adverse event reporting information.

  • Failure to submit a report to FDA in December 2013 and in June 2014 identifying drug products compounded during the previous six-month period.

  • Failure to “thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet its specifications, whether or not the batch has already been distributed (21 CFR 211.192)”.

  • Failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

  • A lack of appropriate laboratory determination of conformance to final specifications for each batch of sterile drug product.

The agency also cited the company for misbranding drugs.

The letter states, “FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation. You should fully implement necessary corrections in order to ensure that the drug products produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity.”

Source: FDA