FDA Dings Chinese Drug Companies, Website

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

Jacobs Pills, Inc.

• Issuing Office: Food and Drug Administration, Division of Pharmaceutical Quality Operations
• Recipient: Philip Altman (supervising pharmacist)
• Date: May 31, 2018 (posted July 3)
• Inspection of facility in Elmsford, N.Y., Feb. 22-28, 2017

Alleged Infractions

• Company does not have valid prescriptions for some of the drugs it produces.
• Some drugs at the facility are compounded using melatonin and domperidone, which aren’t permissible under FDA regulations for compounded drugs.
• Company uses ingredients that don’t comply with identity, strength, quality, and purity standards. ...