Berkeley Biologics, LLC, previously operating as Elutia, Inc. – Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.: FDA Warning Letter (Jun 28, 2024)

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
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,

Passage 2
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:

Passage 3
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:

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 1271
21 CFR 1271.10(a)
21 CFR 1271.15
21 CFR 1271.3(d)
21 CFR 1271.10(a)(1)
21 CFR 1271.3(f)(1)
21 CFR 1271.10(a)(3)
21 CFR 1271.75(a)(1)
21 CFR 1271.75(d)(1)
21 CFR 210
21 CFR 211.100(a)
21 CFR 211.42(c)(10)(iv)
21 CFR 211.160(b)
21 CFR 312