Recently, FDA conducted audit to my company. FDA is known as Food and Drug Administration whereas US has FDA organization and China also has CFDA organization. Its official web site is https://www.fda.gov.
I would like to post their 3 days inspection agenda for your reference. To pass FDA audit is essential for export medical product; let’s well prepare for it.
| Day 1 |
| · Introduction |
| · Opening meeting. |
| · Introduction/Presentation |
| · Plant Overview (Warehouse, Manufacturing and Quality control areas). |
| · Tour on facilities. |
| Lunch |
| · Quality Manual. |
| · Company Organization Chart. |
| · Document Control / Records. |
| · Change Control of Documents |
| · Human Resources (job description, hiring, training). |
| · Quality System Management Review. |
| Day 2 |
| · Daily wrap up. |
| · Environment Control (Clean rooms, ESD and other applicable). |
| · Design Control / History File. |
| · Risk Management. |
| · Device Master Record (DMR). |
| · Change Control of Projects. |
| Lunch |
| · CAPA. |
| · Complaint Handling. |
| · Field Actions / Recall. |
| · Incoming Inspections. |
| · Purchasing / Incoming Goods/Warehouse Activities. |
| Day 3 |
| · Daily wrap up. |
| · Device History Record (DHR). |
| · Internal Audits. |
| · Validation Activities. |
| · Non Conforming Product. |
| Lunch |
| · Quality control (in process and final inspections). |
| · Packaging / labeling. |
| · Handling / Distribution/ Shipping. |
| · Final Release. |
| · Identification and Traceability. |
| Day 4 |
| · Daily wrap up. |
| · Calibration / Maintenance program. |
| · Field service/Technical assistance. |
| · Decontamination / Returned Products. |
| Lunch |
| · Housekeeping (Cleaning, pest control, building maintenance). |
| · Statistical Techniques. |
| · Pending Points. |
| · Inspector’s findings Discussion. |
| · Closing meeting. |