Invitrx Therapeutics, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure of a responsible person to determine and document the eligibility of a cell or tissue donor based upon the results of donor screening and donor testing [21 CFR 1271.50(a)].** For example:

Passage 2

Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes [21 CFR 211.113(b)].** For example:

Passage 3

Failure to satisfy general biological products standards for sterility testing [21 CFR 610.12].** For example:

Passage 4

Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)].** For example, the manufacturing processes for your products have not been validated.

Passage 5

Failure to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit [21 CFR 211.84(a)].** For example, you failed to appropriately test or examine before release for use **(b)(4)** (**(b)(4)**) used in your products and the vials that contain the final product.

Passage 6

Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine the appropriate storage conditions and expiration dates [21 CFR 211.166(a)].** For example, you have assigned two-year expiration dates to your exosome products without supporting data.

Passage 7

Failure to prepare batch production and control records for each batch of drug product produced that include complete information relating to the production and control of each batch, including documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished [21 CFR 211.188(b)].** For example: