CFR section
21 CFR 820.70(e): Production and process controls
PART 820-QUALITY SYSTEM REGULATION · Subpart G-Production and Process Controls
Key facts
| Citation | 21 CFR 820.70(e) |
|---|---|
| Section | Production and process controls |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart G-Production and Process Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (e) Contamination control. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality. |
At a glance
- 100–999 Inspections citing this section
- 10–99 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.