Patrick Weixel Email & Phone Number

Clarksburg, MD, US

Silver Spring, Maryland, United States

Manage the CQS team that is responsible for evaluating regulatory actions such as warning letters for supportability and that the appropriate violations are cited.Work with the Associate Director to develop strategic priorities for the Center and Compliance and Quality StaffEvaluate the supportability of enforcement actions (eg. Injunctions) and monitor.

Silver Spring, Maryland, United States

Review regulatory actions for concurrence and to ensure the appropriate regulatory citations are being cited. Work with the Associate Director of CQS to develop policies and procedures for compliance activities. Mentor and train staff that perform compliance type assignments such as Establishment Inspection reviews.Reviewed Medical Device Single Audit.

Silver Spring, MD

Provided management support to the Medical Device Single Audit Program team, Exports, Imports and Registration and Listing teams.Tasked to address complex assignments under short timeframes.Developed response to an inquiry on an ethylene oxide sterilization facility.Worked with the Division Director to develop policy for the reorganizational structure of.

Silver Spring, MD

Oversee the compliance assignments for the Office of In Vitro Diagnostics to ensure regulatory actions are appropriate and can be supported. Provide training to staff and identify resource and guidance to help staff improve their reviews of compliance assignments.

Silver Spring, MD

Responsible for developing policies and strategies for compliance assignments and work activities. Helped develop recommendations on conducting joint Quality System (QS) and Electronic Product Radiation Control Inspections.Develope work instructions for compliance assignments.Train reviewers on compliance related subjects as well as work instructions..

Silver Spring, Maryland, United States

Review Medical Device Establishment Inspection Reports to determine the supportability of QS observations and classification of the inspection.Determine if regulatory actions such as seizures and injunctions can be supported by CDRH. Determine the classification of Medical Device recalls.Conduct Sterilization, Packaging (sterile barrier system) and.

I evaluated review memos to ensure the appropriate QS regulation was cited and to ensure the recommended EIR classification was appropriate.I determined if CDRH could support regulatory actions such as seizures and injunctions.Conducted training for FDA and the Medical Device industry in areas such as Quality System regulation, Sterilization, Packaging and.

Rockville, MD

Reviewed Establishment Inspection Reports, to determine significance of violations and recommended regulatory actions when significant violations were observed.Conducted Sterilization reviews for the General Hospital Devices Branch and reviewers within other branches.Provided training in areas such as Quality System regulation and Sterilization to CDRH.

Falls Church, VA

Inspected medical device manufacturers to determine compliance with good manufacturing practice regulation, medical device reporting of adverse events and other regulatory requirements.Worked with U.S. Marshalls to seize violative drugs due to violations observed during an inspection I performed.Performed consumer complaint investigations to determine if.

Philadelphia, Pennsylvania, United States

Inspected food, medical device and drug manufacturers and blood banks, to determine if the firms are in compliance with the Food, Drug and Cosmetic Act and good manufacturing practice regulations.Collected food samples for analysis of pesticides, aflatoxins and filth.Conducted recall audit checks to determine the recall notifications were effective..