Regulations

Hand Sanitizer Manufacturer Receives FDA Warning Letter Over CGMPs

Sani-Care Salon Products did not follow CGMP, according to the Agency.

Author Image

By: TOM BRANNA

Editor

US FDA sign

The US Food and Drug Administration issued a Warning Letter to Sani-Care Salon Products, Inc., Cartersville, GA. FDA cited several violations, including: • Failure by the quality control unit to exercise its responsibility to ensure drug products manufactured are in compliance with Current Good Manufacturing Practices (CGMP), and meet established specifications for identity, strength, quality and purity (21 CFR 211.22). • Failure to have for each batch of drug product, appropriate laborato...

Continue reading this story and get 24/7 access to Happi for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Happi Newsletters