- Delivery Method:
- VIA EMAIL CONFIRMED DELIVERY
Recipient NameMr. Tony E. Jones
- Maple Rose Enterprises, Inc, dba Pencol Pharmacy
1325 S. Colorado Blvd
Denver, CO 80222
- Issuing Office:
- Los Angeles District Office
Dear Mr. Jones:
The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter (Ref CMS 520095) dated August 2, 2017. 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.
Lance M. De Souza
Acting Director, Pharmaceutical Quality Operations IV