FDA Inspection
Rechargeable Power Energy North America LLCFDA Inspection 1147060 - Rechargeable Power Energy North America LLC - July 23, 2021
Record Details
This FDA Inspection record concerns Rechargeable Power Energy North America LLC, with an inspection on July 23, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 23, 2021
- Product Type
- Devices
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ID · 5ae59bb1-33b3-4143-91d4-1d6330016178
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147060
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(c)Management review dates
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Rechargeable Power Energy North America LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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