Perhaps the organizational soul searching should begin after receiving one Form 483.
Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.
Comply all the time, not just when FDA announces an inspection.
Get an instant warning letter with repeat Form 483 observations.
Take a quick trip to the FDA’s warning letter page and you’ll see the potential danger that novelty lenses pose.
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.
Establishing a quality policy and quality objectives is considered a Quality 101 type of activity. If an establishment is ISO 9001 or ISO 13485 accredited or claiming to be in compliance with 21 CFR, Part 820, then they better have a posted quality policy and meaningful quality objectives.
A quick review of the violations in 2014 Warning Letters shows that FDA inspectors are scrutinizing multiple areas of operation, from production to receipt of supplies to management responsibilities to CAPA systems.
All device establishments may suffer from the occasional “solecism” or inaccuracies associated with managing a dynamic quality management system, however, when nine Form 483 observations are documented in an agency warning letter, the QA and RA folks are more than likely fast asleep at the proverbial wheel.
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.