Science & Research

Volume III - 5.5 FDA-483 Objectionable Conditions and Practices

DFS Pyramid Logo

Other Laboratory Operations
Food and Drug Administration



Section 5 - Analysts on Inspection




Once an inspection is completed and before leaving the firm, an FDA-483 may be issued to the most responsible person at the site inspected. The FDA-483 itemizes all significant deviations from cGMPs. This may be prepared using TurboEIR, if applicable. If this is the case, please refer to the TurboEIR section for additional guidance.

When writing 483s as an analyst, observations should be:

  • Significant and correlate to regulated products or process inspected.
  • Directly linked to a cGMP regulation for inspections using TurboEIR.
  • Clear, accurate, and complete.
  • Product names and lot numbers should be listed in the observation
  • Listed in the order of significance.
  • Legible if hand written.
  • Related to the inspection. For example, failure to adhere to application commitments is an FDA-483 observation. However, product specifications are not a FDA-483 observation; and they should be discussed with the application Reviewer and addressed as a headquarters issue rather than a field issue.

Page Last Updated: 07/14/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English