Audits and Inspections

FDA sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

GMP non-compliance can spill over and impact patient access to life-saving medications.

Owner of Immuno Biotech, David Noakes, has been sentenced to 15 months in prison over charges of manufacturing, selling, and supplying an unlicensed medicine, as well as money laundering.

Five additional European Union member states have been confirmed by the US Food and Drug Administration (FDA) as capable of performing good manufacturing practice inspections at a level equivalent to that of the United Sates

The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.

Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

The agreement now includes 15 European Union (EU) member states.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.

Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.