Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc. — FDA Warning Letter Findings

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, a. According to your Process Qualification Reports (dated January 17, 2017, March 16, 2020, and April 7, 2023), you only required (b)(4) donors to meet your process qualification acceptance criteria even if some donor batches in the…

Failure to establish laboratory controls that include scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)]. For example: a. You have not established scientifically sound and appropriate specifications and test procedures to assure that VBM, CFM/EFM, and OVM conform to appropriate standards of identity, strength, quality, and…

Failure to have an adequate system necessary to prevent contamination or mix-ups during aseptic processing [21 CFR 211.42(c)(10)(iv)]. For example: a. Your action limits for microbiological monitoring (i.e., active viable air and surface samples) within the critical area (i.e., inside the Biological Safety Cabinet (BSC)) were observed to be greater than (b)(4) colony forming units (CFUs). Such high numbers of microorganisms can contribute to product contamination and pose a potentially significant safety concern. b. You do not perform sampling of critical surfaces in the BSC for microorganisms in association with each production batch. c. Your personnel monitoring sample locations are inadequate for personnel performing aseptic processing. For example, your firm does not conduct personnel monitoring of the forearms/sleeves of operators working in the BSC where your products are aseptically processed.

Failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR 1271.75(a)(1) [21 CFR 1271.75(d)(1)]. For example, you failed to determine as ineligible (b)(4) deceased donors who have a documented medical diagnosis of sepsis. As discussed in the 2007 Guidance for Industry: Eligibility Determination for Donors of Human…