New Inspection Initiatives

1
New Inspection Initiatives

• Jennifer Thomas
• FDA/CBER
• May 20, 1999

2
History

• 1995 - Medical device industry grassroots
  meetings
• 1996 - Inspection initiatives piloted in medical
  device inspections
• 1997 - Inspection initiatives formally adopted
  for medical device inspections
• 1999 - Inspection initiatives piloted in
  remainder of FDA program areas

3
Industry Concern

• Lack of notice for FDA inspections meant key
  people were often not available or had to be
  called back from other activities unnecessary
  disruption of schedules

• Result Preannounced inspections

4
Preannounced inspections

• All inspections except
• blood banks and plasma collection centers
• food firms
• firms that were previously OAI
• short turn around inspections
• GWQAP
• situations requiring immediate and urgent
  attention

5
Preannounced inspections

• Types of Inspections
• Premarket (prelicense, NDA, PMA, etc.)
• Foreign inspections
• Bioresearch monitoring
• GMP or Quality Systems
• Initial inspections of new firms or facilities
• Recall follow-up inspections (non-health hazard)

6
Preannounced inspections

• Inspection will be preannounced at least 5 days
  before the start of the inspection
• Preannouncement, not scheduling
• May advise firm of
• purpose
• products or processes to be covered
• any records or personnel needed at the beginning
  of the inspection

7
Preannounced inspections

• Preapproval inspections - CBER
• Announced by inspection lead per usual procedures
• Biennial inspections
• CBER lead TBLS to preannounce
• ORA lead ORA to preannounce

8
Industry Concern

• Requestors who obtained only the FDA- 483s
  through FOIA had no sense of the firms plans to
  address the deficiencies
• Result Annotated FDA-483s

9
Annotated FDA-483s

• All types of inspections
• Each observation should be annotated with one of
• corrected verified
• reported corrected but not verified
• corrections promised by ??/??/99
• no comment at this time

10
Annotated FDA-483s

• Can annotate after each observation or at the end
  of the FDA-483
• Appropriate to note on the FDA-483 if an
  observation was not corrected from a previous
  inspection
• Has no impact on what observations appear on the
  FDA-483

11
Industry Concern

• Firms generally had no idea of the outcome of an
  inspection unless they were subject to an
  enforcement action or requested the endorsement
  through FOIA
• Result Post inspection notification letters

12
Post inspection notification

• All inspections except for foreign drug
  inspections
• Letter will issue to inspected establishment if
  final inspection classification is
• NAI
• VAI, with no unacceptable profile classes and no
  further action contemplated

13
Post inspection notification

• Letter will be issued by
• ORA for ORA-lead inspections
• OCBQ for CBER-lead inspections