Frequently asked questions
Contact one of our associate to schedule a phone call to discuss specific plan for your company to comply with the new FDA rule.
FDA has not published any guidelines to which manufacturer establishments will adhere to. FDA will published a cGMP guidelines similar to the cGMP for pharmaceutical, medical devices and dietary supplement. Some of these guidelines may address the following: 1- Inspection and testing of raw materials and components. 2- In-process and finished product testing. 3- Product development, design control and validation. 4- Establish and validation of manufacturing processes. 5- Quality Audit and Inspection. 6- Nonconformance and Corrective Actions. 7- Equipment maintenance and calibration. 8- Document and record control and retention. 9- Supplier Quality Audit and Qualification. 10- Customer complaint and product recall.
There is no deadline to submit PMTA but it is strongly recommended to start the process as soon as August 08, 2016. You should consider that your application must be submitted and approved within 24 months.