Sunday 13 November 2011

FDA Form 483

Here is a post on Form-483, which is dreaded by managements of pharmaceutical companies!

What is Form-483?
The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, "Factory Inspection".  FDA Form 483 “Inspectional Observations,” is a form used by the FDA to document and communicate concerns discovered during these inspections. It is also referred to as "Form 483 or merely 483.
 In simple words- “It is a form which consists of all the objectionable observations by a FDA inspector during his/her inspection of manufacturing facility (Pharmaceuticals manufacturing facility in the present context)”

When is a FDA Form 483 issued?  
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 judgement 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 judgement, 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.

 What is the purpose of an FDA Form 483?  
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.

Is the FDA Form 483 intended to be an all-inclusive list of every possible deviation from law and regulation?
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.
What are the implications of the FDA Form 483 for agency enforcement and what happens next?
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.

Disclaimers in form 483-
"This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.”

"The observations noted in this Form FDA-483 [sic] are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements."

Recent trends in form-483-
From 2002 to 2009, the dominant problem area documented on Form FDA 483 was Investigations, which are integral to good CAPA programs. Investigations accounted for 27% of the observations in 2009. The next most problematic areas were Equipment/Facilities/Operations at 11% (2009) and Validation at 10% (2009).
The FDA issued 9,910 483s in 2010, which is at least a 10-year high based on available data. Among these, the top three issues were quality unit deficiencies, inadequate batch failure investigations, and lack of follow-up procedures. For international inspections, the top three were deficient laboratory controls, quality unit deficiencies, and deficient procedures.



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