by Dr. Yashashwini Reddy | Sep 15, 2025
4 Tips to Reduce 483 Observations The FDA issues Form 483 to highlight potential GMP violations observed during inspections. Minimizing these observations requires a proactive approach to compliance and quality culture. 1. Strengthen Documentation Practices Ensure...
by Dr. Yashashwini Reddy | Sep 13, 2025
USFDA Audit Points / Observations 1. Data Integrity & Documentation Missing or incomplete raw data (e.g., deleted chromatograms, overwritten results). Audit trails not reviewed or disabled in computerized systems. Backdating, overwriting, or unauthorized...
by Dr. Yashashwini Reddy | Sep 10, 2025
✅ 4 Tips to Reduce 483 Observations 1. Strengthen Documentation Practices Ensure records are contemporaneous, complete, and accurate (ALCOA+ principles). Use controlled logbooks, proper version control, and audit trails. Train staff to document activities at the time...
by Dr. Yashashwini Reddy | Sep 9, 2025
🧾 Common FDA 483 Observations Related to Cleaning in Pharmaceuticals 1. Inadequate Cleaning Validation Cleaning validation not performed for all product-contact equipment. Worst-case product selection (hardest to clean, most toxic/potent, least soluble) not justified....
by Dr. Yashashwini Reddy | Sep 8, 2025
Difference Between FDA Form 483 and Warning Letter 1. FDA Form 483 (Inspectional Observations) Issued when: FDA inspectors observe potential violations of the Food, Drug, and Cosmetic Act (FD&C Act) during an inspection. Purpose: To notify company management of...
