CFR section
21 CFR 820.150(a): Storage
PART 820-QUALITY SYSTEM REGULATION · Subpart L-Handling, Storage, Distribution, and Installation
Key facts
| Citation | 21 CFR 820.150(a) |
|---|---|
| Section | Storage |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart L-Handling, Storage, Distribution, and Installation |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate. |
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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.