Recent FDA Inspection Trends

1. CAPA Activities/Documentation (21 CFR 820.100 b)

2. Complaints (820.198 a)

3. Quality Audit (820.22)

4. CAPA Procedures (820.100 a)

5. Medical Device Report Procedures (803.17)

Top Five Device Observations Used in Turbo EIR* (FY 2006)

1. CAPA Activities/Documentation (21 CFR 820.100 b)

2. Complaints (820.198 a)

3. Quality Audit (820.22)

4. Process Validation (820.75 a)

5. CAPA Procedures (820.100 a)

Top Five Citations—Biological Devices

1. CAPA Procedures (21 CFR 820.100 a)

2. Nonconforming Product (820.90)

3. Complaints (820.198)

4. Contamination Control (820.70 e)

5. Production and Process Controls (820.70 a)

*Turbo EIR is the software program used by FDA investigators to report any deficiencies and prepare FDA Form-483 inspectional observations. FDA investigators also use this program to write establishment inspection reports (EIRs).

Sources: L Spears, FDA, “Warning Letters and Managing Related Legal Issues,” FDA Inspections Summit, October 2008; D Kalins, FDA, “Warning Letters and Managing Related Legal Issues,” FDA Inspections Summit, October 2007;
M Malarkey, FDA, “Challenges in Biologics Compliance,” FDA Inspections Summit, October 2007.