FDA Warning Letters Week of 06/21/20: For-Cause Inspection & Untitled Letter From A 2018 Inspection

A slow week, two warning letters to compounding pharmacies along with an untitled letter. No device or pharma warning letters posted.

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Drug Warning and Untitled Letters

No letters were issued this week. 

 


Device Warning and Untitled Letters

No letters were issued this week. 

 


Letters to Compounding Pharmacies and Outsourcing Facilities

 

Rapid Equine Solutions, LLC 

Rapid Equine Solutions, LLC received a warning letter on June 12, 2020, based on the outcome of an inspection ending August 9, 2020. This was precipitated by a for-cause inspection following the deaths of three horses treated with compounded drugs from this pharmacy. The drug in question was an oral paste containing Toltrazuril and pyrimethamine. The FDA has acknowledged their product recall dated May 24, 2019. 

 

Nanobots Healthcare, LLC dba Assurance Infusion

Nanobots Healthcare, LLC dba Assurance Infusion received a warning letter on June 12, 2020, based on the outcome of an inspection ending December 3, 2019. FDA acknowledges the firm stopped compounding of sterile drugs in December 2019. 

 

Home Care Pharmacy of Palm Coast Inc 

Home Care Pharmacy of Palm Coast Inc. (Palm Coast, FL) received an untitled letter on May 4, 2020, based on the outcome of an inspection ending April 25, 2018 (not a typo). 

 


BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week. 

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