<span class="archive__title-prefix>Posts Categorized:</span> Enforcement

On April 24, FDA issued a warning letter to contract testing laboratory International Trading Pharm Lab Inc., located in Paterson, N.J. Consumer Safety Officer Niketa Patel conducted the initial inspection October 15-29, 2019. This inspection resulted in a 483 and an Official Action Indicated classification due to data integrity issues. Barbara Unger provided highlights in […]

This week, the FDA posted two warning letters to firms that sold cord blood products without having an active IND or approved BLA. There were also two warning letters posted to the manufacturers of OTC drug products. Along with the usual collection of warning letters regarding COVID related products or devices, FDA posted seven warning […]

This week, FDA posted two warning letters to drug manufacturers and one to a device manufacturer. The warning letter to Stason Pharmaceuticals (Irvine, CA) includes the most granular list of requested data integrity remediation activities that I’ve seen FDA provide, to date. And while not covered here, FDA also posted at least 10 warning letters […]

This week FDA posted two warning letters to device manufacturers and two to drug manufacturers. One of the drug manufacturers produces homeopathic drugs, which continues FDA’s focus on this area of the industry. The other drug manufacturer, located in India, was cited for failures to ensure the quality of recovered solvents. This is reminiscent of […]

This week FDA posted one warning letter to a drug firm and two to compounding pharmacies. One compounding pharmacy received a warning letter from an inspection ending in 2018, and we include the 10-observation form 483. Drug Warning and Untitled Letters Homeocare Laboratories Inc Homeocare Laboratories Inc (Yonkers, NY) received a warning letter on June […]

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 […]

FDA appears to be catching up a bit after a couple of very slow weeks for warning letters issued for drugs, biologics, devices, and compounding pharmacies. This week FDA posted one warning letter to a device firm, two to compounding pharmacies, one to an HCT/P manufacturer, and two to drug firms. Normally we don’t publish […]

FDA continues to post warning letters to the dozens of firms that sell unapproved products to diagnose, treat, and prevent COVID-19 infections and we don’t address those here. However, this week FDA posted one letter to a fertility clinic, two to drug manufacturers, and one to a compounding pharmacy and we cover these below.  Drug […]

FDA continues to issue warning letters to firms that distribute unapproved new drugs to prevent or treat COVID-19 infections. In addition, this week FDA posted three warning letters to drug firms, one to a device firm, and one to a compounding pharmacy. We cover these five below. Drug Warning and Untitled Letters Kumar Organic Products […]

FDA has issued42 warning lettersto firms and individuals who distribute unapproved new drugs to prevent or treat COVID-19 infections. This will continue. FDA continues to issue untitled letters to firms that distribute products that should be regulated under the HCT/P requirements—we cover two this week. This week FDA also posted one letter to a contract […]