Regulatory Focus™ > News Articles > FDA Warning Letter Cites Company for Breaking HCT/P Regulations

FDA Warning Letter Cites Company for Breaking HCT/P Regulations

Posted 02 May 2012 | By Alexander Gaffney, RAC 

A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells, tissues or cellular and tissue-based products (HCT/Ps).

FDA's warning letter specifically cites Young's Owner and Medical Director Thomas E. Young for removing, reprocessing and injecting patients with their own adipose tissue (lipoaspirate), from which Young isolated stem cells. Those stem cells were then injected back into patients, which Young's website claimed would be used as part of a Natural Breast Augmentation procedure.

FDA noted in its letter to Young that this procedure breaks 21 CFR 1271, which covers the reprocessing and alteration of the characteristics of HCT/Ps.

"Specifically, your processing alters the relevant characteristics of the adipose tissue relating to the tissue's utility for reconstruction, repair or replacement. Therefore, the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue. As a result, [your] product does not meet the criterion in 21 CFR 1271.10(a)(1)," FDA wrote in the 20 April letter.

As this reprocessing subjects Young's HCT/P product to FDA regulations governing the manufacturing of biological products, FDA determined Young had failed to follow nearly any necessary requirement for the production of biological products.

FDA's extensive list of violations cites Young alleged failure to ensure aseptic manufacturing processes, written procedures to prevent biological contamination, failure to validate sterilization processes, failure to batch test, investigate adverse reactions, maintain laboratory specifications and standards, establish batch control procedures and quality control procedures, maintain batch records and records of facility maintenance, label products correctly and numerous other violations.

While Young reportedly responded to FDA's initial 483 letter indicating facility deficiencies, FDA notes his letter lacked "sufficient detail to be properly evaluated," and did not include a plan to bring the company's products and facilities into regulatory compliance.


Read more:

FDA Warning Letter - Thomas E. Young, MD. | Owner and Medical Director | Young Medical Spa


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