Also referred to as "Form 483"[3][4][5][6] or merely "483",[4][7] it states thereon that it ... lists observations made by the FDA representative(s) during the inspection of your facility.
[6] Most experts warn that responses should be comprehensive, well-reasoned, well-documented and timely, and that each observation should be addressed individually.
After issuance, manufacturers can use a formal two-tiered dispute resolution process described in the FDA document Guidance for Industry - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP, and they have 30 calendar days to do so.
This section starts with a "disclaimer" that the form contains the observations of the inspector and does not necessarily "represent a final Agency determination regarding your compliance."
[4] The full text is as follows:[17] This document lists observations made by the FDA representative(s) during the inspection of your facility.
If you have any questions, please contact FDA at the phone number and address above.The observations noted in this Form FDA-483 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.The 483 then have a large area for recording the observations, which may be continued on several pages.
[15] The FDA will typically include only significant observations that can be directly linked to a violation of regulations — not suggestions, guidance, or other comments.
[5]) Observations of questionable significance should not be on the 483, but should have been discussed with the firm's management so that they understand how uncorrected problems could become a violation.
'Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.