Inspections News

Inspections News

Log in or Subscribe Now to 483sOnline.com and get the latest inspection news below and directly to your inbox every week. We track the latest enforcement actions, as well as changes in policy and procedures to keep you in the know!

ARTICLES

Drug

German Inspectors Fault Dr. Reddy’s Facility in India, Call for EU Import Ban

German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More
Drug

Hi-Tech Pharmacal Short on Sterility, FDA Says

A New York drugmaker failed to follow proper procedures for sterile handling of products, the FDA said. Read More
Device

Brazil Adds Ireland as MDSAP Accredited Quality Auditor

Brazil’s National Surveillance Agency has added Ireland’s standards authority to its list of accredited organizations to perform quality management system audits under the Medical Device Single Audit Program. Read More
Device

Irish Notified Body Advises Embracing Global Standards as Brexit Looms

Ireland’s national standards organization and notified body is advising devicemakers to become certified to global standards to get ahead of uncertainty surrounding Brexit. Read More
Drug

EMA Defers U.S. GMP Inspections Pending November Activation of Mutual Agreement

The European Medicines Agency is putting off plans for GMP inspections in the U.S. when possible, an EMA spokesperson confirmed, in anticipation of the November launch of a mutual agreement between the EU and U.S. Read More
Drug

FDA Warns Supplement Companies Over Drug Claims, GMP Violations

The FDA continued its crackdown on supplement companies over drug claims and GMP violations, warning companies in New York and Alabama. Read More
Device

FDA Exempts 1,003 Class II Devices From 510(k) Regs — But Not GMPs

The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use. Read More
Device

What Device Manufacturers Can Learn From FDA’s Inspection Data

Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
Drug

Sterile Drugmaker’s Sterility Procedures Found Lacking

The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Read More
Drug

Maryland Drugmaker Warned on Sterility

Sterility concerns and other deficiencies at a Maryland drugmaker could be putting patients at risk, the FDA told Option Care Enterprises in Columbia, Md. in a July 20 warning letter. Read More