B & B Pharmaceuticals, Inc.

CLOSEOUT LETTER B & B Pharmaceuticals, Inc. MARCS-CMS 570613 — February 06, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Matthew T. Johnson Recipient Title President B & B Pharmaceuticals, Inc. 8591 Prairie Trail Drive Suite C-600 Englewood , CO 80112 United States Issuing Office: Division of Pharmaceutical Quality Operations IV 19701 Fairchild Irvine , CA 92612-2506 United States 949-608-2900 Dear Mr. Johnson: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 570613, dated June 4, 2019. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further verify your written commitments. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 02/10/2020 Regulated Product(s) Drugs