Question

100 words each question no plagiarism please

1 What are FDA warning letters

2 What can happen if the company don't correct the violations?

Answer 1

Answer: The FDA warning letters are usually given by the FDA to the organization which doesn't vomoly with law, rules and regulations. The FDA mostly encourages the firms or the individuals to follow the rules and regulations in their practice. In the case where the FDA monitors any kind of deviation in the acceptable practice, it gives warning to that particular firm to rectify the problem or the mistakes before taking any strict enforcement. Hence a kind of warning letter is send to them to improve their shortcomings. The warning letter involves the statement which basically warns the failure and correct the mistakes. It is also mention in the letter that any enforcement could be take place without any further notice.

Answer 2: It is important that the company or any organization to co- operate with the FDA instructions. In the case where the company fails to do so, thethere could be strict action or steps taken by the FDA. After issuing the warning letters, if further improvement have been not found then the FDA would:

• Sieze of the product or the company.
• Injuctions.
• Criminal charges.
• The fine about $100,000 is death is not caused.
• $250,000 fine is death occurs