# Presentation: 778587

## Compliance Program & Warning Letter Pilot

**QSIT Workshops**

## Incorporates Several Program areas
Utilizes QSIT 
Uses Three Levels of Inspection
Establishes OAI

- Utilizes QSIT
- Uses Three Levels of Inspection
- Establishes OAI

**Compliance Program**

## Comments to Compliance Program

**WWW.FDA.GOV/CDRH/COMP/7382.845.HTML**
- November 10, 1999
- Dockets Management Branch

## CP 7382.845QS Situation I

- One or more major nonconformities with QS Regulation
- Total failure to define, document or implement a quality system or one of the seven subsystems
- A major deficiency in one or more elements of the subsystems
- QSIT Guide provides guidance
- Chart A provides seven specific examples, one from each subsystem
- 						more...

## CP7382.845 - QS/GMP Situation I

- Products which clearly do not comply with the manufacturer’s specifications and/or the QS Regulation and which were not adequately addressed by the CAPA subsystem
- Noncorrection of major deficiencies from previous inspections
- Excessive number of minor nonconformities

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## CP7382.845 - QS/GMP Situation II

- Deviations which have a low probability of leading to nonconforming and/or defective devices
- Form FDA 483, Inspectional Observations, serves to inform the establishment of any objectionable findings

## Warning Letter PilotQuality System Inspections

- http://www.fda.gov/ohrms/dockets/	98fr/030899f.txt
- Initiation date March 29, 1999
- Termination date September 8, 2000

## Warning Letter PilotQuality System Inspections

- Following a domestic device quality system inspection which finds current good manufacturing practice (CGMP) deficiencies (situation 1, compliance program (CP) 7382.830 & part V) that warrant a warning letter, the establishment is to be given 15 working days to respond from the issuance date of the list of inspectional observations (FDA483).

## Warning Letter PilotQuality System Inspections

- If the firm’s written response to the FDA483 is deemed be satisfactory by the district office, then a warning letter should not be issued.

## Postinspectional Notification Letter

- When no warning letter is issued by the district office due to the firm’s satisfactory written response, the postinspectional notification letter should be sent to the establishment.

## Warning Letter Pilot Does Not Apply to:

- Non quality system inspections such as mammography, radiological health, and bioresearch inspections;
- Establishments that manufacture devices as well as other FDA regulated products;
- Establishments that manufacture devices that are regulated by the Center for Biologics Evaluation and Research (CBER);

## Warning Letter Pilot Does Not Apply to:

- Recidivous establishments as defined in CP 7382.830;
- Any inspection that uncovers CGMP, premarket notification submission (510(k)), or labeling deficiencies that may cause serious adverse health consequences;

## Warning Letter Pilot Does Not Apply to:

- Any inspection that discloses other significant device violations (e.g. medical device reporting or premarket approval) in addition to quality system, 510(k), or labeling violations which warrant the issuance of a warning letter or regulatory action; or...

## Warning Letter Pilot Does Not Apply to:

- A situation where the firm’s management failed to make promptly available to FDA personnel all requested information and records required by regulations or laws enforced by FDA.

## Thank You