In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply ...
In New York, Los Angeles and about 60 other jurisdictions, including states such as South Carolina, restaurant goers can quickly see the food safety letter grade displayed in the front window. If it’s ...
Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by manufacturers of ...
FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel. Q: FDA publishes redacted Warning Letters and Form 483s with ...
TALLAHASSEE, Florida—Most customers dining out in Florida have no idea what conditions are like inside the restaurant kitchen serving them food. Health inspection reports are posted online, but are ...
As a past president of the Northeast chapter of the International Association of Auto Theft Investigators and a retired New York Police Department detective who spent 20 years in the Auto Crime unit, ...
Zhejiang Bangli Medical Products, a medical dressing manufacturer in China, received a warning letter for limiting an FDA inspection last year, among other breaches of regulations. According to a ...
In 2014, the New York state Department of Motor Vehicles acknowledged the delamination issue affecting certain late production Empire State license plates. After only about five years of continuous ...
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