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.

Shandong Vianor Biotech Co. Linyi Shandong, China (9/12): FDA inspected the firm in May and cited significant GMP violations with finished pharmaceuticals. For example, the firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. The firm was also cited for failing to establish an adequate quality control unit. Additionally, FDA found problems with its equipment cleaning.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm576500.htm

Vicare International Alhambra, CA (9/11): FDA inspected the firm in February and cited GMP violations with dietary supplements. For example, the firm failed to establish specifications for each dietary supplement for the identity and strength of the finished batch. The firm also failed to establish specifications for dietary supplement labels and packaging.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm576386.htm