RenatiLabs Inc.

Selected passages from the FDA letter

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

Passage 1

You failed to reject WJMAX™ lot REN20210205 after this lot failed sterility testing, due to contamination with *Staphylococcus epidermidis*, according to the final report from your contract laboratory dated March 22, 2021. Your Quality Representative and Management with Executive Responsibility approved this lot for release for distribution on June 14, 2021, and June 22, 2021, respectively. You have sold numerous vials of this lot, as recently as **(b)(4)**.

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)].

Passage 3

Failure to establish written procedures for production and process control designed to assure drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)].

Passage 4

Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity [21CFR 211.160(b)].

Passage 5

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

Passage 6

Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)].