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US Food & Drug Administration ( FDA ) Inspections - Pharmaceutical, Medical Device, Biologicals, Dietary Supplements, Food GMP, GLP, GCP, BIMO, QSIT, Pre-Approval, Quality System Inspections  US FDA Inspection References

The following links to US Food and Drug Administration (FDA) resources on FDA inspections such as pharmaceutical inspections, medical device inspections, food inspections, biologicals inspections, and cosmetics inspections. If you have any questions regarding FDA inspections, please do not hesitate to contact Global Regulatory Inc at 403-770-1994 or email us.

  • US Food and Drug Administration (FDA) Field Management Directives

    The primary vehicle for distributing procedural information/policy on the management of the US Food and Drug Administration's Office of Regulatory Affairs (ORA) field activities.

  • US Food and Drug Administration (FDA) Guides to Inspections of...

    US Food and Drug Adminsitration (FDA) guidance documents written to assist FDA personnel in applying FDA's regulations, policies and procedures during specific types of FDA pharmaceutical inspections, medical device inspections, biological inspections, food inspections, or cosmetics inspections or for specific pharmaceutical, medical devices, food, cosmetics, and biological manufacturing processes.

  • US Food and Drug Administration (FDA) IOM: Investigations Operations Manual

    US Food and Drug Adminsitration (FDA) primary procedure manual for FDA personnel performing FDA pharmaceutical inspections, medical device inspections, biological inspections, food inspections, or cosmetics inspections and special investigations.

  • US Food and Drug Administration (FDA) Guide to International Inspections  and Travel

    US Food and Drug Adminsitration (FDA) procedure manual for FDA personnel performing FDA pharmaceutical inspections, medical device inspections, biological inspections, food inspections, or cosmetics inspections and other FDA-related activities abroad.

  • US Food and Drug Administration (FDA) Inspection Technical Guides

    US Food and Drug Adminsitration (FDA) guidance documents that provide FDA personnel with technical background in a specific piece of equipment. or a specific manufacturing or laboratory procedure, or a specific inspectional technique, such as Ethylene Oxide Sterilization, Steam Pressure for Retorts and Autoclaves, Diathermy, Stroboscope, Thermocouple Surfaces, Heat Sensitive Sensors, Ultrasound in Food, Drugs and Devices, Screening Electronic Components, Computer in FDA regulated industries, Air Velocity Meters, Evaluation of Production, Pyrogens, Reverse Osmosis, Water Activity, Bacterial Endotoxins, Expiration Dating and Stability Testing, Lyophilization of Parenterals, Measurement of Relative Humidity, Radiation Protection, Water for Pharmaceutical Use,

Educational, Training, and Informational Resources
For more information or assistance with your USFDA GMP, GLP, GCP, QSR, QSIT, Pre-Approval, or Foreign pharmaceutical, medical device, biologics, food, cosmetics, or nutraceutical inspections , please contact Global Regulatory.com at 403-770-1994, email us or Submit Regulatory Requests
 
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US FDA Related News

 
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2012-04-11 00:00:00
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A California seafood importer and processor has agreed to a consent decree ... FDA announces plans to pilot end-stage kidney disease technology in new program
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Innovation Pathway aims to reduce time and cost of bringing safe and effect... FDA enters consent decree with cheese producer due to Listeria contamination
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Washington state cheese processor agrees to FDA food safety action A Was... FDA proposes lower risk classification for certain tuberculosis tests
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Lower classification will support CDC recommendations The Food and Drug ... New FDA guidance on considerations used in device approval, de novo decisions
2012-04-01 00:00:00
Clinical data, risks, benefits and patient risk tolerance outlined in proce... Obama administration takes action to address tobacco epidemic
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Today the U.S. Food and Drug Administration (FDA) released two separate dra... FDA approves additional blood test for viruses linked to leukemia, neurologic diseases
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Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to ... FDA proposes lower risk classification for certain tuberculosis tests Lower classification will support CDC recommendations
2012-03-25 00:00:00
The Food and Drug Administration issued a proposed rule today that would en... OSHA and the Society for Chemical Hazard Communication renew Alliance to promote best practices to reduce worker exposures to chemical hazards
2012-03-23 00:00:00
WASHINGTON - Promoting best practices to reduce worker exposure to hazardou... USDA Warns of Additional Fraudulent Letters and Calls
2012-03-23 00:00:00
WASHINGTON, March 23, 2012--USDA officials have been notified that addition... USDA Publishes Final Rule to Restore the Nation's Forests Through Science and Collaboration
2012-03-23 00:00:00
Secretary Vilsack announces publication of the final land management planni... USDA Trade Mission to Create Opportunities for U.S. Agriculture in China
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Nearly 40 U.S. Companies to Form Business Ties and Joint Ventures WASHING... Obama Administration Announces New Funding for Biomass Research and Development Initiative
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Research to advance next generation biofuels and renewable energy technolog... US EPA Administrator Lisa P. Jackson Testimony Before the U.S. Senate, Committee on Environment and Public Works
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