FDA Inspection


FDA inspection is done primarily to determine if the inspected company/process complies with FDA guidelines and meets the terms of Federal Food, Drug, and Cosmetic Act (FDCA).

Significantly, other than the businesses that manufacture FDA-regulated products, clinical trial sites and nonclinical laboratories conducting plant, animal or microorganism studies used in FDA applications for drugs, biologics, or devices come directly under the purview of FDA and hence, can be inspected.

There are 2 basic types of FDA inspections: Surveillance inspection - is routine FDA inspection, whereas the compliance inspection is based on specific objective, such as compliant or other suspected specific problem like unreported Adverse Events (AEs).
Elements pertinent to FDA inspection are:

Exit Interview

FDA inspection ends with an exit interview and that interview, incidentally seals the fate of the inspected company. In this exit interview, FDA presents a written report of its inspection, followed by a debriefing. Report presented in the exit interview is mainly prepared for the internal use of FDA and the inspected company remains non-permitted to see the report.

The exit interview should be attended by the inspection host, scribe, and senior management from both Quality and Manufacturing. Others may attend if appropriate. - Read More >>

FORM 483
After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit. To provide the facility with its own written list of discrepancies noted during the inspection, FDA developed form FDA 483, "Notice of Inspectional Observations," issued by the field investigator. Form 483 should contain only those observations that can be directly linked to a violation of regulations-not suggestions, guidance, or other comments. Although the 483 does not contain references to the regulations, each observation should be directly traceable to a section of the applicable regulations. - Read More >>

Warning Letter
A Warning Letter is a communication to the firm that has been reviewed within several levels of the FDA, including the district office and the Center at FDA's headquarters. The Warning Letter generally states that the firm has made products that are adulterated, violating the Food, Drug, and Cosmetic Act and that the firm has a very limited amount of time to address the problem(s) before the FDA takes further regulatory action against the firm, the adulterated product, and responsible individuals. - Read More >>

Inspection Response Report
Inspection Response Program or IRP is a written policy and procedures of issues pertaining to inspection.
  • It ensures all relevant policies will be well thought out.
  • Senior members of company management will approve both the policy and their implementation.
  • SOP's are written. They are communicated to all who are involved in hosting regulatory inspectors. Hence you ensure uniform application of such policies throughout the firm.
  • And then it also provides a basis for periodic review as regulations and other practice change thorough out the year.
    -