Signature Biologics Illegally Marketing Cord Product

A 12/1/21-12/16/21 FDA inspection at Signature Biologics in Irving, TX, documented that the firm manufactures Signature Cord, a product derived from human umbilical cord for allogeneic use. A just-released 9/18 Warning Letter says the firm has distributed the product directly to healthcare professionals and medical facilities for use in patients.

The letter says the firm’s product requires a BLA or IND to be legally marketed, neither of which it has. FDA also says it documented evidence of significant deviations from current good manufacturing practice (CGMP) requirements during its inspection. Specific deviations cited are:

• failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
• failing to have an adequate system for monitoring environmental conditions in an aseptic processing areas;
• failing to have laboratory controls include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
• failing to laboratory test each batch of drug product purporting to be pyrogen-free to determine conformance to such requirements;
• failing to establish written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess;
• failing to have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions; and
• failing to establish a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates.

FDA says the firm’s responses to the inspection observations listed on a form FDA-483 are not adequate to address the deficiencies. The agency acknowledges the firm’s commitment to voluntarily suspend the manufacture and distribution of Signature Cord.

The company was told to respond with a list of specific steps it has taken or plans to take to address any violations and prevent their recurrence, with any documentation necessary to show that the matters have been addressed and a schedule for completing the corrections.