Biologics

Microvascular Tissue Marketing Unapproved New Drug

A 3/31-4/6 FDA inspection at the Microvascular Tissue facility in San Diego, CA, determined that the company’s mVASC, derived from hypodermis recovered from donors and marketed for allogenic use, is an unapproved new drug and an unlicensed biological product. A 12/3 Warning Letter says the mVASC product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) that does not qualify for any regulatory exemptions.

The letter notes that the product fails to meet the minimal manipulation criterion in the applicable regulations because the firm’s processing alters the original relevant characteristics of hypodermal tissue related to its ability for reconstruction, repair, or replacement. It also says mVASC fails to meet the criterion that HCT/Ps be intended for homologous use only.

The inspection also found these significant current good manufacturing practice (CGMP) violations:

failure to establish adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality that they are purported or represented to possess; and
failure to conduct at least one test to verify the identity of each component of a drug product, using specific identity tests if they exist.

FDA says Microvascular’s response to the inspection observations is inadequate. It notes the company’s position that its product should be regulated solely under section 361 of the Public Health Service Act, a position that FDA rejects.

The company was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome