Inspections, Compliance, Enforcement, and Criminal Investigations
Braintree Laboratories, Inc. Close out Letter 4/27/11
| Public Health Service Food and Drug Administration |
New England District |
Department of Health and Human Services
April 27, 2011
Mr. Harry P. Keegan
President/ Owner
Braintree Laboratories, Inc.
60 Columbian Street
Braintree, MA 02185
Dear Mr. Keegan:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 10, 2010 (NWE-17-10W) during an inspection of your facility on December 30, 2010 – January 21, 2011. Based on our evaluation, it appears that you have addressed the violations contained in this 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.
If you have any further questions, please feel free to call me at 781-587-7491.
Karen Archdeacon
Compliance Officer
New England District
