After each inspection, FDA prepares a written list of discrepancies noted during the inspection. The list is known as Form 483 or “Notice of Inspectional Observations”, issued by the field investigator. In case no serious discrepancies are found in the investigation, FDA will not issue Form 483.
Usually, Form 483 contain observations that are directly linked to a violation of regulations-not ideas, remarks, or other direction. Again, Form 483 should not contain references to the regulations; however, each observation made by the investigator should be directly traceable to a section of the applicable regulations.
After receiving form 483, the recipient should respond to the FDA notifying them about each item and agreement and should also mention a timeline for correction. Regardless of the number of observations, response of the recipient has to be submitted within 15 calendar days. However, response to Form 483 is not mandatory, yet a good response usually helps the company avoid receiving a Warning Letter from the FDA, withholding of product approval, or plant shut-down.
Before issuing Form 483, FDA always encourages deciphering issues through informal mechanisms, however, after issuance, FDA requires the recipient to 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.
