Inspections and Audits

ARTICLES

483 Roundup: FDA Hits Four Firms for GMP, Other Failures

The FDA cited four devicemakers for problems with their complaint procedures, change controls and quality oversight, among other deficiencies. Read More

FDA Hits Houston Devicemaker With Lengthy Warning Letter

Houston-based medical devicemaker Talon received a lengthy FDA warning letter for design process and quality control issues following an inspection of the firm’s manufacturing facility. Read More

FDA Warns Clinicon for Lax Testing, Validation of Sterilization Processes

The FDA issued a June 20 warning letter to Clinicon for quality system lapses related to its SureProbe Class II sterile probe following an April 3-4 inspection of the firm’s Oceanside, California facility. Read More

Radiation Safety Apparel Maker Fails to Report Complaints

Devicemaker Protech Leaded Eyewear failed to develop Medical Device Reporting procedures and didn’t investigate complaints, the FDA’s Dec. 6-14, 2018 inspection of its Lake Park, Florida plant revealed. Read More

483 Roundup: FDA Cites Three Firms for Complaints, Validations

The FDA rapped three devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Read More

Cosmetic Devicemaker Fails to Submit MDRs on Time

The FDA cited Carol Cole Company for failure to submit timely medical device reports of its devices that use microcurrents to tone, firm and reduce wrinkles, according to a Form 483 that was issued following a March 20-22 inspection of the firm’s Vista, Calif. facility. Read More

International Hospital Products Cited for Numerous QMS Failures

Process validation failures, documentation lapses and failure to establish corrective and preventive actions were just a few of the quality lapses found during a March 15-19 inspection of International Hospital Products’ Littleton, Colorado facility. Read More

FDA Finds Weak Process Controls at Anesthesia Associates

A March 11-14 inspection of Anesthesia Associates’ San Marcos, California facility revealed inadequate process control procedures. Read More

Houston Devicemaker Called Out for Numerous Violations

The FDA cited Houston, Texas devicemaker Talon for a multitude of transgressions at its facility, including problems with validations and complaint investigations. Read More

Singapore Diagnostics Maker Fails to Establish SOPs for Investigations

Failure to establish standard operating procedures for investigations landed Singapore-based diagnostics maker MP Biomedicals Asia Pacific in hot water with the FDA following a Dec. 10-12, 2018 inspection of its Singapore facility. Read More