CFR section
21 CFR 211.84(c)(2): Testing and approval or rejection of components, drug product containers, and closures
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart E-Control of Components and Drug Product Containers and Closures
Key facts
| Citation | 21 CFR 211.84(c)(2) |
|---|---|
| Section | Testing and approval or rejection of components, drug product containers, and closures |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart E-Control of Components and Drug Product Containers and Closures |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs |
| Regulation text (excerpt) | (2) The containers shall be opened, sampled, and resealed in a manner designed to prevent contamination of their contents and contamination of other components, drug product containers, or closures. |
At a glance
- 10–99 Inspections citing this section
- 1–9 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.