- PerkinElmer Health Sciences, Inc.
- Issuing Office:
10903 New Hampshire Avenue
Silver Spring, MD 20993
JAN 13, 2017
Kay A. Taylor
VP of Global Regulatory, Quality and Clinical Affairs
940 Winter Street
Waltham, MA 02451
Dear Ms. Taylor:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 407102 dated October 23, 2014. 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 assess the adequacy and sustainability of these conections.
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.
Donald J. St. Pierre
Acting Deputy Director for
Patient Safety and Product Quality
Office of InVitro Diagnotics and
Center tor Devices and Radiological Health