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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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FDA Issues Form 483 to Ambra Health for Failing to Report Recall, Customer Complaints

October 11, 2022
Ambra Health drew a Form 483 for failing to report a recall to the FDA and properly investigate customer complaints, among other lapses observed during an inspection of its New York City facility. Read More

Product Testing, Acceptance Activities Get General Physiotherapy a Form 483

October 10, 2022
General Physiotherapy was hit with a Form 483 after an FDA investigator observed product testing and other quality deficiencies at the company’s Earth City, Mo., facility. Read More

American Contract Systems Draws Form 483 Over Validation Lapses

October 5, 2022
The FDA handed American Contract Systems a Form 483 for validation issues and other quality lapses observed during an inspection of its Temple Terrace, Fla., facility April 5-8. Read More

Device Company Draws Form 483 for Inadequate Validation, Controls

October 4, 2022
The FDA rapped Zoll Medical in a Form 483 for not properly validating its processes and for inadequate controls at its Rumford, R.I., plant to ensure products conformed to specifications. Read More

Dental Supply Firm Draws Form 483 for Not Investigating Complaints

September 27, 2022
Zuga Medical did not properly investigate hundreds of complaints about failures of its dental implants over a five-year period, the FDA said in a Form 483 issued after a March 24 to April 12 inspection of the company’s Chagrin Falls, Ohio, facility. Read More

Siemens Slapped with 483 for Slow Response to Complaints about Multiple Devices

September 26, 2022
Siemens Healthcare Diagnostics delayed responding to complaints about several of its devices not working properly for months on 12 occasions and also delayed notifying the FDA and correcting the problems. Read More

Dentonics Gets Form 483 for Inadequate and Missing Procedures

September 23, 2022
Not following standard operating procedures (SOP) and lack of key procedures, such as for device master records and labeling products, landed Dentonics a Form 483 after an FDA inspection of its Monroe, N.C., facility. Read More

InBios International Rapped for Not Following SOPs

September 21, 2022
InBios International’s facility in Seattle, Wash., drew a Form 483 from the FDA for not following its standard operating procedures (SOP) for several activities. Read More

Xintec Gets Form 483 for Issues with Device History Records

September 20, 2022
Inadequate device history records (DHRs) and other deficiencies landed Xintec, also known as Convergent Laser Technologies, a Form 483 after an inspection of its Alameda, Calif., facility. Read More

FDA Gives CAREstream Medical Form 483 for Documentation Failures

September 14, 2022
CAREstream Medical drew an FDA Form 483 citing various failures in documentation following an agency inspection of the company’s Maitland, Fla., facility from April 25-27. Read More

Spok Docked for Incomplete CAPAs and Inadequate Design Controls

September 6, 2022
Alexandria, Va.-based Spok received a Form 483 after an April inspection by the FDA found incomplete corrective and preventive action (CAPA) procedures and design control lapses. Read More

FDA Questions LV Liberty Vision’s Product Validation, Verification Methods

August 30, 2022
LV Liberty Vision lacked proper design validation and verification testing, the FDA said in a Form 483 issued following an inspection of the ophthalmology devicemaker’s Portsmouth, N.H., facility. Read More
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