Dear Sir or Madame from Burt’s Pharmacy LLC,

to handle your received warning letter in the most efficient way, we would like to offer the following services:

1. Raw Material procurement and testing based on current FDA requirements and corresponding supplier qualification activities.

2. Establishing suitable procedures for cleaning activities of infrastructure and equipment, as well as training of staff with training certifcation.

3. Establishing a suitable Quality Assurance function wit hthe required experience and competency to implement state of the art release procedures and In Process Controls. 

4. Implementation of Pest Control meassures and procedures for the entire GxP area.

Please contact us if you require our support. We currently estmate an effort of 3 to 5 months to fully implement all meassures.