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  5. B & B Pharmaceuticals, Inc. - 570613 - 02/06/2020
  1. Warning Letters

CLOSEOUT LETTER

B & B Pharmaceuticals, Inc. MARCS-CMS 570613 —

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

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