Vitti Labs, LLC — FDA Warning Letter Findings

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) used in the manufacture of your products and the vials that contain the final product.

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)]. For example, you have not established scientifically sound and appropriate specifications and test procedures to assure that your products conform to appropriate standards of identity, strength, quality, and purity.

Failure to have ceilings of smooth, hard surfaces that are easily cleanable in an aseptic processing area [21 CFR 211.42(c)(10)(i)]. Specifically, during the inspection, our investigators observed unused pieces of equipment, remnants of a surgical suite operated by a previous tenant of your facility, suspended from the ceiling of your cleanroom such that the ceiling and attached, unused equipment is not easily cleanable.

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: a. The aseptic processes used to manufacture your products have not been validated (e.g., by performing media fill simulations) since your firm’s manufacturing operations began in July 2020. These products…

Failure to establish and follow 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)-(b)]. Specifically: a. You have not adequately validated the manufacturing processes for your products with respect to identity, strength, quality, and purity. Your validation did not include amniotic membrane processing 3 . Additionally, your validation for umbilical cord processing only included sterility testing and endotoxin testing as measurements of product attributes. b. At the time of the FDA inspection, your written procedures for processing your umbilical cord derived products did not reflect your actual practice. The procedures in effect at the start of the inspection indicate that (b)(4) should be removed from the umbilical cord tissue for further processing into your finished products. In contrast, you indicated that your firm’s practice has been to use the entire umbilical cord tissue except for (b)(4) .

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 has assigned a two-year expiration date to your products without adequate data regarding the stability characteristics of the products. For example, the shelf-life study performed, completed…