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360 Search Results Found For: "Medical Device"

Date

Issue #

2025-02-14

Issue #1154

[…] pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue features observations pertaining […]

2025-02-14

Quarterly Report QSR-25Q1

Highlights issues related to deficiencies in personnel and training.

2025-01-31

Issue # 1153

[…] pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue features observations pertaining […]

2025-01-15

Issue #1152

[…] pertaining to quality systems, manufacturing controls and medical device manufacturers. This issue features observations pertaining […]

2025-01-15

Annual Report – FY 2024

Please log in to view this content.   If your company is not yet a […]

2025-01-15

Facility Inspection List from 7/2024 – 9/2024

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

Issue #1151

[…] pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue features observations pertaining […]

2024-12-16

Issue #1150

[…] pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue features observations pertaining […]

2024-12-08

NoRedactions_IC_APEXDentalSleepLab,LLC,483,3012716038,02-22-2024-4

[…] as the procedure required. OBSERVATION 4 The medical device(s) label did not have a unique […]

2024-12-02

Is your internal audit program robust enough to cover your next FDA inspection? 

In a recent FDA inspection, a medical device manufacturer was cited for failure to conduct […]