Pharmaceutical

FDA slaps dietary supplement maker with warning letter over significant violations

dietary supplements pills probiotics FDA slaps dietary supplement maker with warning letter over significant violations California-based dietary supplement manufacturer Herbal Sciences International received a warning letter from the Food and Drug Administration (FDA) following an inspection of the plant during which agency inspectors “identified a number of significant violations of FDA’s Current Good Manufacturing Practices (CGMP) in the Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements Regulations.”

The company manufactures dietary supplements under the names Xiao Ke Wan (Diabetic Formula), Ping Ya San (Pressure Reduce Formula), Ruan Jian Xiao Zhen Tang (Tumor, Cancer Fighter #1, 10:1), She Hu Xiao Zhong Wan (Prostate Ease), An He Jian Fei Wan (An Ho Diet Pills); Geng Nian Fu Bao Wan (New Spring Menopause Formula), and Quiang Jing By Shen Wan (Kidney Essence Power).

The violations included the manufacturer’s failure to provide specifications for each dietary supplement for identity, purity, strength and composition of the finished batch, and for limits on types of contaminants that may affect the quality of the finished batch. The company was also cited for not keeping required records and failing to establish and follow written procedures for the responsibilities of the quality control operations.

Herbal Sciences International was also found in violation of misbranding its products because serving sizes were incorrect, nutritional information was noncompliant, and the company failed to include a domestic address or phone number for users to contact in the event of an adverse effect.

The FDA advised the company to take prompt action to correct and prevent the reoccurrence of the violations, otherwise “failure to do so may result in an enforcement action by FDA without further notice, including, without limitation, seizure and injunction.”

Source: FDA Warning Letter