CLOSEOUT LETTER
Prescription Dispensing Laboratories Inc. MARCS-CMS 579286 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Drugs
- Recipient:
-
Recipient NameRaymond L. Solano
-
Recipient TitlePresident
- Prescription Dispensing Laboratories Inc.
101 Commercial Parkway
Cedar Park, TX 78613
United States-
- Rsolano@pdlabs.net
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
United States
Mr. Solano:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Case # 579286; Dated: July 30, 2019]. 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.
If you have questions regarding the contents of this letter, you may contact John Diehl via phone at 214-253-5288 or email at john.diehl@fda.hhs.gov.
Sincerely,
/S/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II