A cell therapy outfit in California that manufactures a human umbilical cord derived cellular product and exosome products is facing a warning from the FDA over several major observations related to quality.
The FDA notes the site’s “deficient donor screening practices, inadequate aseptic practices, unvalidated manufacturing,” and the “risk that your products may be contaminated with microorganisms or have other serious product quality defects.”
Invitrx Therapeutics received the warning letter earlier this month for its site in Lake Forest, CA, which was inspected in March and later halted some manufacturing.
The letter, which had 10 major observations, states that Invitrx had failed to determine and document the eligibility of a cell or tissue donor based upon the results of screening and testing and noted that it had not reviewed “relevant medical records” it received from the umbilical cord tissue suppliers to determine eligibility.
The letter also revealed that since operations began, Invitrx has “failed to determine and document the eligibility of hundreds of tissue donors.” Tissues from these donors were reported to be used to manufacture products.
The agency also noted that Invitrx had failed to validate the aseptic process to manufacture several of its products, with investigators also observing “primary product containers” for items that are supposed to be sterile being stored on a shelf in an “open bag” in the cleanroom. Caps that are received in bulk also did not have further cleaning or sterilization.
As for the site’s environmental monitoring procedures, the letter said that Invitrx did not perform environmental monitoring of its aseptic processing area or have written procedures in place at the time of inspection.
Two-year expiration dates for some products were set without supporting data and incubators used for “sterility testing” were also not qualified for that use. Several other QC issues involving written procedures and other testing were also noted.
The FDA said that “corrective actions” had been taken and suspended all clinical drug substance manufacturing and drug product batches at the Lake Forest facility “intended for use in domestic clinical trials.” However, this is not entirely satisfactory for the FDA.
“It is unclear from this statement whether you have suspended the manufacturing of all products identified in the FDA-483. Further, it is unclear, based on your response, whether you will manufacture your products at any of your other locations for distribution. Your response also describes ‘interim control[s]’ you plan to implement prior to completing certain corrective actions, which suggests that Invitrx will resume manufacturing prior to adequately addressing the existing deficiencies,” the letter said.
It is also noted that the FDA cannot fully assess the company’s responses to several of the observations as they do not provide sufficient details on the “corrective actions,” and they lack a timeline for the completion of all the actions. The response also does not properly address the failure to have an IND in effect for clinical investigations of Invitrx’s products. However, Invitrx is committed to recalling distributed products.
Invitrx has been pulled into a “regulatory meeting” with the FDA to discuss the steps that have been taken since the March inspection. The meeting is on the books for the middle of December.
Endpoints News reached out to Invitrx for a statement on the letter but did not receive a response by press time.