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Compliance Program
Manual for FDA Staff

SUBJECT:

INSPECTION OF MEDICAL DEVICE MANUFACTURERS

IMPLEMENTATION DATE

October 1, 2000
  COMPLETION DATE

September 30, 2004
DATA REPORTING

PRODUCT CODES

PRODUCT/ASSIGNMENT CODES
73-91 82845A 42830L -- All Level 1 (Abbreviated) Inspections

82845B 42830C -- All Level 2 (Baseline) Inspections

82845C -- All Level 3 (Compliance Follow-up)

Inspections

82845G -- All For Cause Inspections

82845S -- Report Time spent on Assessment of

Firm’s Sterilization processes

81011 --Report Time spent on Assessment of Firm’s MDR Practices

81845T --Report Time spent on Assessment of Firm’s Tracking Practices

81845R -- Report Time spent on Assessment of Firm’s Corrections and Removals Practices

   

Field Reporting Requirements

483s: A copy of all FDA-483s and the corresponding copy of FACTS EI record with endorsement should be sent to HFZ-306 for entry into the national 483 database.

EIRs: All EIRs resulting in a Warning Letter or a Post-Inspectional Notification Letter based on the firm’s response to a violative inspection, i.e., Warning Letter Pilot, should be sent to CDRH, HFZ-306. All recommendations for administrative/regulatory action should include the EIR, FDA-483, and exhibits. The recommendations should be sent to HFZ-306.

 

FACTS: Using FACTS V.2. report all activities (including preparation and arrangement of inspection, writing and reviewing correspondence) under the following operation codes:
Operation Code Type of Operation
11 Foreign Inspection
12 Domestic Inspection
13 Domestic Investigation
53 Field Examination/Test
41 Sample Analysis
31 Sample Collection

Refer to existing policy in the IOM, Subchapter 180, page 26.

Warning Letters: A copy of all Warning Letters related to all requirements covered in this compliance program should be sent to HFZ-306 and HFC-210.

Comment:

  • If the district wishes to obtain comment from CDRH for any EIR, the district should attach a cover memorandum to the EIR outlining the issues to be considered by the Office of Compliance (OC). This policy does not relieve the district from COMSTAT via FACTS reporting requirements.
    •
  • FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.

NOTE: Design Control and Sterilization checklists are no longer needed.

This guidance document represents the agency’s current thinking on the enforcement of the Quality System/Good Manufacturing Practices (QS/GMP), Medical Device Reporting (MDR), Medical Device Tracking, Corrections and Removals (CAR), and the Registration and Listing regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

 

 

PAC Guidance

PROGRAM

PACs
Quality System Level 1 (82845A)
Level 2 (82845B)
Level 3 (82845C)
For Cause 82845G
MDR 81011
Tracking 81845T
CAR 81845R
Sterilization Inspections* 82845S

 

 

* These inspections are sub-inspections of the Quality System Program. When conducting sterilization review as part of the Production and Process Controls subsystem, report only the time spent reviewing the sterilization process during the Quality System inspection, if covered under PAC 82845S. Also, report PACs, 81011, 81845T and 81845R, as applicable.

The above PAC Guidance is provided for investigator reference only. It’s sole purpose is to "jog your memory", to assist in appropriate and accurate PAC reporting activity.