A letter dated January 25 stated that, following an inspection in July 2012, FDA listed alleged GMP violations in the Form FDA 483. The company’s responses to the 483 were deemed insufficient by FDA and the Agency sent a warning letter.
The Agency listed the alleged violations as:
1. A lack of master manufacturing records related to your packaging and labeling operations;
2. No listing of any product specifications for the products the company packages and labels;
3. Incomplete batch production records;
4. Product labels that did not match up to the COA (certificate of analysis);
5. And a failure to make and keep written procedures for returned dietary supplements
To read the full letter, please click here.