Dirkjan: Created page with "To understand FDA Inspections the following concepts & definitions are important during inspections: * A Bottum-up inspection was the FDA standard ins..."

2020-08-25T07:19:37Z

Created page with "To understand FDA Inspections the following concepts & definitions are important during inspections: * A Bottum-up inspection was the FDA standard ins..."

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To understand FDA Inspections the following concepts & definitions are important during inspections:
* A [[Bottum-up inspection|Bottum-up inspection]] was the FDA standard inspection prior to 1998.
* [[Comprehensive inspection|Comprehensive inspection]] is an inspection on all elements of a firms quality system.
* [[Directed inspection|Directed inspection]] is an inspection performed on specific elements of a firm's quality system.
* [[Establishment Inspection Report|Establishment Inspection Report]], is a report completed by the FDA after an inspection.
* Form [[FDA 482|FDA 482]], is a notice of inspection.
* Form [[FDA 483|FDA 483]], contains the inspectional observations.
* [[Quality System Inspection Technique|Quality System Inspection Technique]] (QSIT) is the FDA's current inspection technique.
* A [[Table-Top Inspection|Table-Top Inspection]] is an inspection strategy of reviewing a firm's written procedures and records.
* A [[Top-Down Inspection|Top-Down Inspection]] is the FDA's latest inspection strategy in which inspectors are taught to evaluate the quality system and sampling quality system records
* [[Track I Inspection|Track I Inspection]] is a limitted inspection of the quality system conduced every two years
* [[Track II Inspection|Track II Inspection]] is a complete audit every four years
* [[Situation I|Situation I]] conditions are those conditions that provide evidence that there are significant errors in the manufacturers production process leading to defective devices.
* [[Situation II|Situation II]] conditions are those conditions that are not meeting the Situation I conditions.
* A [[Warning Letter|Warning Letter]] is an administrative action typically issued to firms with Situation I conditions.

=Inspection frequency=
The FDA does not need a warrant to inspect any device manufacturer. Refusal to permit the inspection is a violation of [[The Act|The Act]].

The following situations enter into the inspection assesment:
# Manufacturers whose last inspection was violative and who provided little or no compelling evidence of corrective measures
# Manufacures who received [[510(k)|510(k)]] clearance for a high-risk device within the past 12 months and who have not been inspected within the previous 2 years.
# Manufacturers of class II and class III devices who have never been inspected
# Manufacturers who have newly registered
# Manufacturers with a recently cleared [[510(k)|510(k)]]
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FDA Inspections - Revision history

Dirkjan: Created page with "To understand FDA Inspections the following concepts & definitions are important during inspections: * A Bottum-up inspection was the FDA standard ins..."