Patty Harvey

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About Patty Harvey

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So far Patty Harvey has created 7 blog entries.

Food Industry | FDA Draft Guidance on Multiple Entity Registration Requirements

Do you own a food company that rents space to conduct any part of your business? Or, alternatively, do you own a facility that you rent to a food company? If you answered yes to either of the above questions, keep reading to find out the answer to one question you might have, “Do I need to register with the FDA?”

By |2018-08-28T14:27:02+00:00August 28th, 2018|CGMP, FDA Enforcement News, Food, Supplier Management|

NASDA and FDA Work Together to Implement the Produce Safety Rule

Scott Gottlieb summarized the latest work the FDA is doing to implement the Produce Safety Rule (mandated by FSMA) in a letter addressed to NASDA. FDA and NASDA have worked toward ensuring objectivity and consistency for produce inspections. They have also been working on alternatives to the traditional 483 inspectional observation form. See the complete run-through of this crucial letter for the food industry.

By |2018-08-18T01:45:03+00:00August 16th, 2018|CGMP, FDA Enforcement News, Food, Form FDA 483, FSMA|

FDA Sent These 4 Warning Letters for Food Companies | June 2018

We took a snapshot of the 4 warning letters the FDA sent to food companies last month. Food violations ranged from failing to label products (a lot!) to failing to train supervisors. From companies in California, New York, and more, here they are: LNZRO Pizza Empire, Inc, Syracuse, NY – 3 violations: Fails to conduct hazard analysis for products [...]

By |2018-08-24T08:18:53+00:00July 16th, 2018|CGMP, FDA Warning Letters, Food, FSMA|