As per the United States Food and Drug Administration (USFDA) website the observations in Form 483 notifies the company's management of objectionable conditions.
A mail send to the company remained unanswered at the time of filing the story.
"At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company's senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously," as per the information available on the FDA website.
