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

Last week, the FDA posted two warning letters to pharmaceutical firms. One, issued to an OTC manufacturer and API repackager, highlighted product released to the market without a batch record. The other, issued to a homeopathic drug manufacturer, cited a lack of validation in critical areas. Drug Warning and Untitled Letters Kalchem International, Inc. Kalchem […]

It is 2020, do you know what your vendors/suppliers/contract manufacturing organizations are doing? Companies that use contract manufacturing organizations (CMOs) are ultimately responsible for ensuring product quality and compliance with GMPs. Thus, it pays in more ways than one to be aware of recent FDA quality-related citations at CMOs and other vendors. Below is a […]

Last week, the FDA issued two Warning Letters to pharma companies for GMP violations. One cited data integrity failures among other observations at an OTC manufacturer while the second cited a drug repackager for cleaning validation issues. Interestingly, cleaning validation (or lack thereof), was a focus of one of theprevious week’s Warning Letters. Drug Warning […]

Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan […]

Another busy week for FDA continuing to issue warning letters to firms who claim to diagnose or treat COVID-19.This week there were also several warning letters issued for failure to comply with the food foreign supplier verification program, the most recent Tobacco Control Act, and food production GMPs. Among the areas we follow, there were […]

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 […]