GMP News - Quality Assurance

The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.

Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. Both a directive and a regulation are now in place.

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.