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October 27, 2020

Everything Aquatic – 610530 – 10/06/2020

Delivery Method: Via Overnight Delivery Product: Animal & VeterinaryDrugs Issuing Office: Center for Veterinary Medicine United States WARNING LETTER Date: October 6, 2020 RE: Unapproved New […]
October 27, 2020

KVK-Tech, Inc. – 608236 – 10/08/2020

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Anthony Tabasso Recipient Title President and CEO KVK-Tech, Inc. 110 Terry DriveNewtown, PA 18940United States Issuing […]
October 27, 2020

Mr Frags, LLC – 611295 – 10/19/2020

Delivery Method: Via Overnight Delivery Product: Animal & VeterinaryDrugs Recipient: Recipient Name Jason Weage/Jason Coral Mr Frags, LLC 5598 Highbury Dr SEAda, MI 49301United States [email protected] […]
October 27, 2020

Quimica Magna de Mexico, S.A. de C.V. – 608751 – 10/15/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jorge Varela Recipient Title CEO Quimica Magna de Mexico, S.A. de C.V. Telares No. 130La Aurora25298 […]
October 27, 2020

Shilpa Medicare Limited – 607877 – 10/09/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Vishnukant Chaturbhuj Bhutada Recipient Title Managing Director Shilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135KarnatakaIndia Issuing Office: […]
October 27, 2020

Inter-governmental Working Meeting on Drug Compounding, October 10-11, 2019

On October 10-11, 2019, FDA convened its eighth inter-governmental working meeting of state government officials. Attendees included officials from state boards of pharmacy and state health […]
October 26, 2020

Compounding Information for States

FDA’s compounding program closely collaborates with state officials. FDA collaborates with state officials in a variety of ways, including by sharing information about compounders who engage […]
October 26, 2020

From Our Perspective: The Orange Book at 40: A valued FDA resource continually enhanced by user input

Captain Kendra Stewart, Orange Book supervisor, discusses the Orange Book’s 40th Anniversary October 31, 2020, marks the 40th anniversary of the first official publication of the […]
October 26, 2020

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

On October 23, 2020, the Food and Drug Administration approved the next-generation sequencing (NGS)-based FoundationOne CDx test (Foundation Medicine, Inc.) as a companion diagnostic to identify […]
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