Kimera Labs, 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 to establish 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 2

Failure to establish written procedures for production and process controls 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 3

Failure to test your non-penicillin drug products for the presence of penicillin although a reasonable possibility exists that the non-penicillin drug products have been exposed to cross contamination with penicillin [21 CFR 211.176]. For example, **(b)(4)** is one of the components in the Complete Media for your XoGlo® and XoGlo®Pro products, and you have not performed testing of these products for penicillin prior to final product release.

Passage 4

Failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)]. For example, at the time of the inspection:

Passage 5

Failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods [21 CFR 211.165(e)]. For example, at the time of the inspection, you had not validated the test methods used for testing XoGlo® and XoGlo®Pro for identity, strength, quality, and purity.