Valley Biosystems

CLOSEOUT LETTER Valley Biosystems MARCS-CMS 632553 — October 14, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Biologics Recipient: Recipient Name Steve Cello Recipient Title Site Director Valley Biosystems 1265 Triangle Court West Sacramento , CA 95605 United States Issuing Office: Center for Biologics Evaluation and Research (CBER) United States Dear Mr. Cello: The United States Food and Drug Administration (FDA) acknowledges receipt of your letter dated August 24, 2022, responding to the Warning Letter (WL) issued by FDA on August 3, 2022, to Valley Biosystems Inc. (VBS). The WL pertained to the firm’s conduct involving Good Laboratory Practice (GLP) nonclinical studies S18-10688 and S19-10708. We reviewed your response stating that VBS developed a post-inspection action plan to remediate the inspectional findings and that VBS was acquired by Altasciences USA LLC (Altasciences). We acknowledge your firm’s commitment to no longer perform FDA regulated GLP nonclinical studies under 21 CFR Part 58, and note that VBS and Altasciences have taken steps to cease conducting such GLP studies for the VBS clients. Your action has resolved the remaining issues described in the August 3, 2022, Warning Letter. Sincerely, /S/ Melissa J. Mendoza, JD Acting Director Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research cc: Eric Pittman, Director FDA ORA-BIMO West Content current as of: 10/18/2022 Regulated Product(s) Biologics