Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Hubei Danjiangkou Danao Pharmaceutical Co. Danjiangkou, Hubei Province, China (11/6): FDA inspected the firm in August and cited significant GMP deviations with its active pharmaceutical ingredients (API). For example, the firm failed to demonstrate that its manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. The firm did not validate the processes used to manufacture numerous batches prior to commercial distribution. Additionally, the firm’s quality unit failed to approve changes that potentially impact API quality.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm585015.htm

Vita-Pure, Inc. Roselle, NJ (11/8): FDA inspected the firm in March and documented significant GMP violations with its dietary supplements. For example, the firm failed to establish product specifications for each dietary supplement that it manufactures. The firm also failed to conduct at least one appropriate test or examination to verify the identity of a component prior to its use.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm585616.htm