# FDA RESUME - Unknown Company - Unknown Date

Source: https://www.keypedia.com/records/resume/unknown-company/4cb2deae-2197-440f-a214-2f7379783a74

> FDA RESUME for Unknown Company on Unknown Date. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: RESUME
- Summary: Catherine Jean Laufmann served as a Consumer Safety Officer at the FDA's Office of Regulatory Affairs (ORA) from 2002 to 2018, focusing on medical device inspections. Her tenure included roles within the Division of Medical Products and Tobacco Inspection Branch (DMPTIB) and the Foreign Device Cadre. Laufmann conducted over 90 establishment inspections, emphasizing compliance with Good Manufacturing Practices (GMP) and Quality System Regulations (QSR). Her inspections spanned a wide range of medical devices, including implantable orthopedic devices, fetal monitors, and external defibrillators.

During her career, Laufmann frequently acted as an Acting Supervisory Consumer Safety Officer, evaluating inspection findings and recommending follow-up actions. She also provided training on complex issues identified during inspections. Her work led to numerous Warning Letters and Official Action Indicated cases, supporting regulatory enforcement actions such as detentions.

Laufmann's inspections adhered to a regulatory framework that included For Cause, Comprehensive Level II Quality System Inspection Technique (QSIT), and Compliance Follow-Up Inspections. Her efforts contributed to regulatory actions like Warning Letters and Regulatory Meetings, and she played a key role in inspections under Consent Decree of Permanent Injunction.

Her achievements include receiving an unofficial Hall of Fame award for the highest number of Warning Letter cases in a year. Her work required collaboration with FDA headquarters and involved significant international travel to inspect foreign medical device manufacturing facilities.

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)