Inspections News

Inspections News

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ARTICLES

Drug

Homeopathic Drugmaker Violated Production Standards, FDA Says

A New York maker of homeopathic medicines that include toxic ingredients ran afoul of the FDA because it made drug-like claims for its products but did not manufacture them to the standards invoked by the claims, the agency said in a warning letter. Read More
Drug

FDA Officials Highlight Compliance and Warning Letter Trends

CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
Device

Good News, Bad News for BD: OK on Lead Tests, But Other Problems

The FDA said it could find no evidence that tubes made by Becton Dickinson for Magellan Diagnostics’ blood lead-level testing devices contributed to inaccurate readings from the devices, which Magellan had suggested as a cause. Read More
Device

Chinese Medical Equipment Barred From Import by FDA

The FDA cut off imports from a Chinese manufacturer of hospital beds, stretchers and operating-room tables after an inspection discovered multiple violations of quality standards, the agency said in a warning letter. Read More
Drug

PDA Conference: Baxter Cuts 483 Rate With Quality Matrix

Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More
Drug

FDA Officials Highlight Compliance and Warning Letter Trends

CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
Device

EpiPen Manufacturer Bungled Response to Complaints of Failures, FDA Says

A company that manufactures EpiPens for Mylan neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths — and the company did not recall potentially defective injectors from the marketplace even after identifying a fault in a critical injector component, the FDA said in a warning letter. Read More
Device

U.S., Brazil Add New Auditing Bodies for MDSAP

The FDA and Brazil’s National Surveillance Agency have added new auditing bodies to their list of organizations eligible to conduct quality management system audits for the Medical Device Single Audit Program. Read More
Drug

Compounder Lost Exemption From Rules, Then Violated Them, FDA Said

A Georgia compounding pharmacy ran afoul of the FDA after losing the exemption from agency rules that is extended to compounders that limit their production to filling prescriptions for individual patients, the FDA said in a warning letter. Read More
Drug

India’s Hetero Labs Violated GMP Standards, FDA Said

The FDA flagged a Hetero Labs drugmaking plant near Hyderabad, India for multiple violations of good manufacturing practice standards. Read More