We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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
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 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
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’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
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
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
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
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
CellEra has received a Form 483 for not having proper procedures for handling complaints and corrective actions and for other deficiencies observed during an April 11-14 inspection of the company’s Monroe, Ohio, facility. Read More
Aggredyne drew a Form 483 from the FDA for deficient design change validations and other lapses following an inspection of its Houston, Texas, manufacturing facility from March 29 to April 14. Read More