FDA Inspection
Rechargeable Power Energy North America LLCFDA Inspection 1071491 - Rechargeable Power Energy North America LLC - November 09, 2018
Record Details
This FDA Inspection record concerns Rechargeable Power Energy North America LLC, with an inspection on November 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 9, 2018
- Product Type
- Devices
View Company Profile
ID · 048da33c-a06b-4c24-8fb3-7025b0ba6c8f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1071491
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Enforcement
- Warning Letter
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 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 |
|---|---|---|---|
| July 23, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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