Kimera Labs, Inc. — FDA Warning Letter Findings

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.

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: a. You failed to validate your written cleaning procedure for your laminar flow (b)(4) and your cleanrooms where your products are manufactured. Additionally, you failed to establish the effectiveness of disinfectants used in this procedure. b. Your written procedure for cleaning the (b)(4) and cleanroom did not specify the contact time for disinfectants. c. Your firm documented major and minor cleaning of (b)(4) and cleanrooms used in manufacturing of your products; however, your written procedures did not define the minor and major cleaning methods.

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 [21 CFR 211.160(b)]. Specifically, you have not established scientifically sound and appropriate specifications to assure that your products conform to appropriate standards of identity, strength, quality, and purity. Your specifications are listed as “tentative.” 5. 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.

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.

Failure to ensure that each lot of components, drug product containers, and closures are withheld from use 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)]. Specifically, your firm lacks evidence, such as testing, to demonstrate components meet all specifications of identity, strength, quality, and purity. For example, you lack evidence that (b)(4) media, used in production of XoGlo® and XoGlo®Pro, were tested prior to release. Additionally, these two components are labeled “For research use only” but are incorporated into products that are injected into/used by humans.

Each batch of drug product purporting to be sterile and/or pyrogen-free is not laboratory tested to determine conformance to such requirements [21 CFR 211.167(a)]. For example: a. Sterility samples of Amnio2x® are frozen prior to sterility testing. Freezing product has the potential to destroy any microbial content in the samples before testing; therefore, contamination, if present, may not be detected. b. Your written procedure for Amnio2x® specifies testing of (b)(4) vials for sterility regardless of lot size, which may consist of as many as (b)(4) vials. This does not ensure that sterility samples are representative of the lot size.

Written records are not always made of investigations into unexplained discrepancies or the failure of a batch or any of its components to meet specifications whether or not the batch has already been distributed [21 CFR 211.192]. Specifically, you failed to document investigations for all unexplained discrepancies or the failure of batch to meet specifications. For example, you failed to document an investigation into the positive sterility result obtained for XoGlo®Pro lot 4000078P. All (b)(4) vials of this lot were distributed.

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: a. Your firm has failed to validate the aseptic processes used to manufacture XoGlo®, XoGlo®Pro, and Amnio2X®. These products purport to be sterile and are expected to be sterile. b. You have not established appropriate…

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 appropriate storage conditions and expiration dates [21 CFR 211.166(a)]. Specifically, your firm assigned a one-year expiration date to XoGlo® and XoGlo®Pro lots without adequate data regarding the stability characteristics of the products. All product used for the stability study was from…