Owen Biosciences, Inc.

Selected passages from the FDA letter

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

Passage 1

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity. Your firm also failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.160(b) and 211.165(a)).

Passage 2

Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).

Passage 3

Failure to address violations may be cause for FDA to withhold issuance of Export Certificates. Any violations of CGMP requirements may also be cause for FDA to withhold approval of new applications or supplements listing your firm as a drug manufacturer. We may re-inspect to verify that you have completed corrective actions to address any violations.