Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking ...
Issues that are considered objectionable conditions or compliance violations by FDA inspectors are itemized in a Form 483 or a warning letter. These notices follow a standard process, beginning with ...
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories.
A drug production facility in Durham run by a Chinese company violated multiple safety regulations, according to the FDA. A ...
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing ...
Following an FDA inspection of its North Carolina facility that found ... Shanghai-based CARsgen Therapeutics has been issued a Warning Letter.
The U.S. Food and Drug Administration's (FDA) warning letter to Agena Bioscience, issued on March 21, 2024, marks a significant shift in enforcement priorities, targeting the improper labeling of ...
Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a ...
The U.S. Food and Drug Administration issued warning letters to two Chinese third-party testing firms on Wednesday, citing ...
Most Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments
Issues that are considered objectionable conditions or compliance violations by FDA inspectors are itemized in a Form 483 or a warning letter. These notices follow a standard process, beginning with ...
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