FDA Inspections
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To understand FDA Inspections the following concepts & definitions are important during inspections:
- A Bottum-up inspection was the FDA standard inspection prior to 1998.
- Comprehensive inspection is an inspection on all elements of a firms quality system.
- Directed inspection is an inspection performed on specific elements of a firm's quality system.
- Establishment Inspection Report, is a report completed by the FDA after an inspection.
- Form FDA 482, is a notice of inspection.
- Form FDA 483, contains the inspectional observations.
- Quality System Inspection Technique (QSIT) is the FDA's current inspection technique.
- A Table-Top Inspection is an inspection strategy of reviewing a firm's written procedures and records.
- A 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 is a limitted inspection of the quality system conduced every two years
- Track II Inspection is a complete audit every four years
- 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 conditions are those conditions that are not meeting the Situation I conditions.
- A 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 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) 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)
