Quality/GMPs

Articles

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

FDA Finds CGMP Violations at Canadian Facility 

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

Oklahoma Facility Given FDA Warning

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

FDA Sends Mylan Warning Letter

The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.

Georgia Facility Receives FDA Warning Letter

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

MHRA to Resume On-Site Inspections in September 2020

Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

FDA May Delay Approval of Drugs Where Necessary Inspection Is Not Feasible

Industry should be seeking more information from FDA on how it will restart its current inspection program.

Will FDA Inspections Ever Be the Same?

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines. 

FDA Works to Resume On-site Domestic Inspections

483s and Warning Letters Point to Inadequate Quality Oversight

Solving Pharma’s Quality Unit Identity Crisis

FDA can better monitor quality production of domestic versus foreign firms. 

Audits and Inspections