- Delivery Method:
- VIA Electronic Mail
Recipient NameMr. Whoojong (Peter) I. Song
- Beauty Manufacturing Solutions Corp.
1250 Freeport Pkwy
Coppell, TX 75019
- Issuing Office:
- Dallas District Office
Dear Mr. Song:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS No. 535116) dated January 12, 2018 and our meeting with you on December 12, 2018. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
John W. Diehl, M.S.
Commander, U.S. Public Health Service
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,