Process validation Findings

Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity that they are purported or represented to possess, as required by 21 CFR 211.100(a). For example, your firm has not validated the manufacturing processes for your umbilical cord derived products with respect to identity, strength, quality, and purity.

Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. Your response to our request for records or other information pursuant to section 704(a)(4) indicates that you manufactured and distributed (b)(4) APIs to the United States (U.S.) without adequate process validation, which is critical to ensure the quality and purity of the API. For example, in response to our request on July 7, 2025, that you provide the process validation summary report for all U.S.-marketed APIs, you indicated that these APIs were still in development and were not commercial products. Therefore, formal documents such as standard operating procedures had not been finalized. However, FDA data shows that your (b)(4) APIs were distributed to 503A compounding pharmacies. Process validation evaluates the soundness of design and state of control of a process throughout its life cycle. Each significant stage of a manufacturing process must be designed appropriately and must ensure the quality of raw-material inputs, in-process materials, and finished drugs. Process-qualification studies determine whether an initial state of control has been established. Without adequate process validation, your firm lacks the basic assurance that you can reproducibly deliver products that meet specifications. See FDA’s guidance document Process Validation: General Principles and Practices at https://www.fda.gov/media/71021/download for general principles and approaches that FDA considers appropriate elements of process validation. In response to this letter, provide the following: A detailed summary of your validation program for ensuring a state of control throughout the product life cycle, along with associated procedures. Describe your program for process performance qualification (PPQ) and the ongoing monitoring of both intra-batch and inter-batch variations to ensure a continuing state of control. A timeline for performing PPQ for each of your marketed drug products. Process performance protocol(s) and written procedures for the qualification of equipment and facilities. A risk assessment and any follow-up actions to be taken for the APIs your firm produced and distributed without first performing any process-validation studies.

Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Your firm failed to establish adequate 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 failed to adequately validate the processes used to manufacture your OTC drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an adequate ongoing program…

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.