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

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

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