Is a 483 the same as a warning letter?

Is a 483 the same as a warning letter?

An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice. You need to respond in writing within 15 days of receiving both a 483 and a warning letter.

How long do you have to respond to a 483?

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15 days

Does the FDA issue fines?

Criminal Fines for Food Drug and Cosmetic Act Violations Misdemeanor fines under the Act may reach $500,000 under some circumstances. The Criminal Fine Enforcement Act of 1994 (Public Law 98-596) provides for fines for violations of Federal law.

What makes a drug adulterated?

(a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act provides that a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not …

What does FD&C stand for?

Federal Food, Drug, and Cosmetic Act

How often does the FDA check for compliance?

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every two years