Discover industry-tested approaches to strengthen quality systems and navigate regulatory scrutiny in this comprehensive ...

This warning letter is a quintessential example of FDA’s enforcement ... Akan was provided an opportunity to response to these observations, however, FDA found this response to be insufficient.

The warning letter starts off innocently ... practice to fabricate records and results for samples that were not taken,” the FDA said. In response to the data falsification observations ...

Lykos has previously published its response to ... As an example, nearly 30% of participants in Lykos' Phase 2 studies reported prior use, which was shared with FDA before establishing the ...

According to the FDA, the tubes are not being produced in conformity with good manufacturing practice and have led to false positive lead test results.

A bacteria known as Pseudomonas aeruginosa was found in multiple water samples taken ... In the FDA’s letter, the agency said the company’s response to finding microorganisms in water and ...