CLOSEOUT LETTER
Ambco Electronics, A California Corp
- Recipient:
- Ambco Electronics, A California Corp
United States
- Issuing Office:
United States
| |
| Food and Drug Administration Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human Services
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
July 2, 2015
Dennis L Daniels, President and CEO
Ambco Electronics
15052 Red Hill Ave, Suite D
Tustin, CA, 92780
Dear Mr. Daniels:
The Food and Drug Administration has evaluated your corrective actions to FDA Warning Letter (WL) #36-14, dated September 26, 2014, including your written responses to the WL, and the results of our follow up inspection that closed May 5, 2015. Based on our evaluation, it appears you have addressed the violations contained in the subject Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
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/
Alonza E. Cruse, Director
Los Angeles District