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October 02, 2020
The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.
September 18, 2020
The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.
September 02, 2020
The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.
The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.
August 20, 2020
The UK's MHRA will resume on-site risk based GxP inspections from September 2020.
A new FDA guidance provides answers to 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.
August 18, 2020
FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.
August 05, 2020
FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.
July 20, 2020
Industry should be seeking more information from FDA on how it will restart its current inspection program.
July 13, 2020
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.