Inspections News

Device

Biomechanics Company Gets Handed a 483

The FDA issued a Form 483 to Hand Biomechanics, citing problems with its complaint process and failure to submit MDR reports. Read More
Device

AMD Medicom Nets 483 for CAPA Problems

The FDA cited AMD Medicom for lacking adequate procedures for CAPA actions, and for failing to maintain a device master record and to establish contamination prevention procedures. Read More
Drug

FDA Warns Canadian Drugmaker for Refusing Photography During Inspection

The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that products are adulterated. Read More
Drug

FDA Draws Up Blueprint for Pre-Approval Facility Reviews

The FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals. Read More
Device

MDSAP Participants, Regulators Consider the Program’s Future

MDSAP participants identified actions for improving the program at 2017 RAPS Convergence. Read More
Device

Preservation Solutions Draws FDA Warning for GMP Violations

Preservation Solutions, a Wisconsin-based provider of organ preservation and transplant solutions, was hit with an FDA warning letter for GMP nonconformities. Read More
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