A slow week, two warning letters to compounding pharmacies along with an untitled letter. No device or pharma warning letters posted.
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 its 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.
Get a Demo
We can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.