GenoGenix LLC — FDA Warning Letter Findings

Your firm failed 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)).

Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations). 4 Specifically, you do not have any documented procedures for reporting adverse events. Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm produced drug products with materials that had not been verified to assure that they did not contribute endotoxin contamination that may be objectionable given the product’s intended use. FDA investigators also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example…

An operator placed components within the ISO (b)(4) hood that had the potential to block the movement of first air to critical in-process operations.

Your cleanroom is outfitted with HEPA filters directly adjacent to the return vents in the ceiling. This design may prevent the dilution of particle-laden air by HEPA filtered air. Therefore, your firm has no assurance of proper air circulation within your cleanroom where aseptic production occurs.

An operator blocked first air by placing gloved hands directly over open sterile containers.

Some of your facility’s drug products did not include a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient on the label or container. Examples include Rapamycin, Clear Mind 150, Alpha Lipoic Acid, and Epithalon.

Your firm failed to establish and follow written procedures prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to ensure that the reprocessed batches conform to all established standards, specifications, and characteristics (21 CFR 211.115(a)).

Your firm lacks adequate routine environmental monitoring. Specifically, your firm has never performed personnel or environmental monitoring during the production of drug products.

Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)).

Operators did not disinfect materials at each transition from areas of lower quality air to areas of higher quality air.

Personnel engaged in aseptic processing while exposing skin within the ISO (b)(4) aseptic processing area.

Some of your facility’s drug products did not include the following information on the container: a. Information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088. b. Directions for use, including, as appropriate, dosage and administration. Examples include Immune Defense Nasal Spray.

Your facility compounded drug products using bulk drug substances that are not eligible for the use in compounding under section 503B, including 5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and nicotinamide adenine dinucleotide (NAD+). Drug products compounded using 5-Amino-1MQ and NAD+ are not eligible for the exemptions provided by section 503B, because 5-Amino-1MQ and NAD+ do not appear on the 503B bulks list and are not used to compound a drug that appears on the…

Your firm failed to conduct (b)(4) testing on (b)(4) used to sterilize drug products. Therefore, you do not have assurance that the (b)(4) throughout use.

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Your firm handled hazardous drug products without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.

Personnel performing sterile operations never conducted media fills. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.

Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)). In addition, FDA investigators noted that your firm released and distributed several drug products in which the strength did not meet the label claim. For example, your firm released and distributed…

Your facility failed to submit a report to FDA upon initially registering as an outsourcing facility in February 2025 and in June 2025 identifying the drug products that you compounded during the previous 6-month period.

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO (b)(4) area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

Your facility is designed and operated in a way that may permit the influx of lesser quality air into a higher quality air area. Specifically, your cleanroom sliding glass doors have visible gaps that could compromise the integrity of the controlled environment. These openings create pathways for uncontrolled air movement and potential contamination transfer.

An operator manually touched a product contact surface by reaching into a bag of stoppers with gloved hands, then hand stoppered vials of drug product.

Your firm failed to establish a system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Your production areas are difficult to clean and contain porous surfaces.