Tim Wright—Please Investigate Tissue Tagging Records at MiMedx

This behavior is UNACCEPTABLE and you are RESPONSIBLE  for this behavior. All investors need an update on HOW BAD your business truly is. Please file your financials or let the market know why you can’t. This is simply a disgrace and Director Rick Barry and Chairwoman Wilsey know better and should be embarrassed.

This is from a former who is disgusted by your lack of leadership and knows of numerous compliance ongoing “Compliance Irregularities

All companies operating under AATB must meet H1.400 distribution standards.  MiMedx has never fully complied with this standard. MiMedx, at periods,  has been years behind in processing distribution records.  They had just thrown the cards in a drawer in the quality area and let them accumulate.  MiMedx has not come close to meeting it’s obligation to have distribution records for all shipped product.

H1.400 Distribution Records

Distribution records shall be maintained by the tissue bank that ships tissue (including unfinished or as yet unreleased tissue) to other entities. These records shall be designed to permit tissue to be traced from the donor to a Consignee or End-User, and from a

Consignee or End-User back to the donor. Tissue Distribution records shall include:

 

1)    Date of order placement;

2)    Name and address of Consignee;

3)    Name of individual placing the order;

4)    Type and quantity of tissue ordered;

5)    Information pertaining to tissue shipped including:

  1. a) Identification number(s) of tissue(s);
  1. b) Collection and/or expiration date of tissue;
  1. c) Date of shipment;
  1. d) Type and amount of refrigerant, if any, used for shipment;
  1. e) Mode of transportation and/or courier; and
  1. f) Name of the staff member filling the order.

6)    Identifying information, if available, about the intended Recipient.

H1.410 Responsibility

The tissue bank shall establish Recipient follow-up data collection protocols.