Frequently asked questions FDA

Q1: When is an FDA Form 483 issued?
A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
Q: What is the purpose of an FDA Form 483?
A: The FDA Form 483 notifies the company’s management of objectionable conditions. 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.

Q2: What is the purpose of an FDA Form 483? A: The FDA Form 483 notifies the company’s management of objectionable conditions. 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. Q3: Is the FDA Form 483 intended to be an all-inclusive list of every possible deviation from law and regulation? A: No, it’s not. The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist. Q2: How is the FDA Form 483 shared with the company? A: FDA Form 483s are discussed with a company’s management at the conclusion of the inspection. Each observation is read and discussed so that there is a full understanding of what the observations are and what they mean. Q3: What are the implications of the FDA Form 483 for agency enforcement and what happens next? A: The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD &C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health

Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data

A London court has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified data to the Medicines and Healthcare products Regulatory Agency (MHRA) in order to obtain a Marketing Authorization for a product. This was preceded by extensive investigations by the authority, during which thousands of scientific data files were analyzed and reviewed. The defendant was sentenced to eight and seven months on two counts. He will not have to spend time in prison as the sentence was suspended for 18 months. However, both the defendant and the company must pay a fine of £50,000. The defendant must also pay the prosecution costs of over £80,000. A confiscation order of over £1 million, reflecting the profit from the crime, have already been confiscated. What happened? A press release dated 15 March 2024 states that "Evotrox Oral Solutions (a liquid solution containing the active ingredient levothyroxine) was licensed in 2006 in three strengths for the treatment of hypothyroidism (underactive thyroid)." As usual, the manufacturer also had to submit stability data as part of the licence application. Back in 2008, reports emerged that the product was not stable for the whole duration of the shelf-life claimed in the original licence application. The MHRA took this as an occasion to launch an investigation. During this investigation, "the company continued to submit falsified data to the MHRA to try to support the medicine’s stability and effectiveness." A comprehensive series of independent analyses by the MHRA and a detailed evaluation of the data seized from laboratory computers brought the falsifications to light. This culminated in the termination of the marketing authorisations by the MHRA in 2013 and subsequent criminal prosecution. Statement of the MHRA In the press release, Andy Morling, MHRA Deputy Director (Criminal Enforcement), emphasizes the complexity of the investigations. "Whilst the MHRA found no evidence that patients were harmed, the fact that the manufacturers were prepared to put them at risk by knowingly supplying a substandard product is very concerning." All in all, "this is a shocking case of a pharmaceutical company that thought it was above the law and was not required to uphold our stringent standards for safety, quality and effectiveness."