FDA Warns New York Drugmaker for Lack of Product Testing, Quality Unit
A lack of product testing and a deficient quality unit resulted in a warning letter for New York-based Scientific Solutions Global.
A Dec. 11, 2018-Jan. 2, 2019 inspection of the firm’s manufacturing facility found the firm had no processes in place for testing the drug products it released. The firm also had no testing procedures for confirming the identity of raw materials.
Further, the letter highlighted that the firm said it didn’t perform any process validation for any of the drug products it manufactured.
The agency found multiple products made by the firm to be unapproved new drugs. The firm’s OTC Biotemper Cold Relief Therapy product was sold as containing an active ingredient, arnica, which the letter notes “is not included in the OTC Drug Review for external analgesic or any other uses.”