FDA posted two drug-related Warning Letters and one untitled letter to a firm marketing a cell-based product. One of the drug Warning Letters concerned a compounding pharmacy.

Drug Warning and Untitled Letters

YOUNG FOUNDATIONAL HEALTH CENTER, LLC

Young Foundational Health Center, LLC (Largo, FL) received an untitled letter from CBER based on content of their website and social media. The firm markets a cellular-based product advertised to treat a variety of diseases and medical conditions. The product is also determined to be an HTC/P that must be supported by an IND or a BLA.

COSMAX USA, INC 

Cosmax USA, Inc (Ridgefield Park, NJ) received a Warning Letter on October 15, 2020, based on the outcome of an inspection ending March 17, 2020.  The firm manufactures over the counter drug products; sunscreens are mentioned specifically as a product that they manufacture. FDA recommends that the firm hire a qualified consultant(s) to assist them in coming into GMP compliance. While this was not an observation they note that the company manufactures multiple products using glycerin and does not apparently test for the presence of diethylene glycol. They also note that the Quality Unit does not have the authority to exercise their responsibility. The deficiencies identified include but are not limited to:

  • Failure to investigate OOL microbiological results for water used as a raw material in their products. Other water drops were subsequently found to be out-of-limit (OOL) and in multiple instances did not identify the organism. FDA states the firm “...lacked control of the upstream part of your water system.” 
  • The firm did not have bulk hold time studies for multiple drug products that were held for as long as six months before filling.  
  • The firm failed to clean and sanitize non-dedicated production tanks according to the written procedure. The firm admitted that some employees “did not know how to adequately clean the tanks…” The cleaning process lacked documentation. For example, a bucket of cleaning solution was used without a label and its content and preparation were not supported by documentation. 

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy/Outsourcing Facilities

SURGERY PHARMACY SERVICES INC

Surgery Pharmacy Services Inc (Chattanooga, TN) received a Warning Letter on October 9, 2020, based on the outcome of an inspection ending December 6, 2019. Note that the FDA does not cite violations of 21 CFR 211, but rather with the requirements of the FD&C Act.

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