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360 Search Results Found For: "Medical Device"
Date
Issue #
2025-02-14
[…] pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue features observations pertaining […]
2025-02-14
Highlights issues related to deficiencies in personnel and training.
2025-01-31
[…] pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue features observations pertaining […]
2025-01-15
[…] pertaining to quality systems, manufacturing controls and medical device manufacturers. This issue features observations pertaining […]
2025-01-15
Please log in to view this content. If your company is not yet a […]
2025-01-15
A summary of FDA inspections that were conducted between 7/2024 and 9/2024. The report includes whether or not a facility received a 483, length of inspection, investigator, and CFR citation where available.
2025-01-01
[…] pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue features observations pertaining […]
2024-12-16
[…] pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue features observations pertaining […]
2024-12-08
[…] as the procedure required. OBSERVATION 4 The medical device(s) label did not have a unique […]
2024-12-02
In a recent FDA inspection, a medical device manufacturer was cited for failure to conduct […]
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