FDA Inspection
Good Clean Love, Inc.Good Clean Love, Inc. – FDA Inspection, Sep 29, 2017
Record Details
This FDA Inspection record concerns Good Clean Love, Inc., with an inspection on September 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ea453bb5-d067-4864-b945-8ca30e546ebe
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1027056
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Good Clean Love, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 13, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Good Clean Love, Inc.
- FDA Inspection 1167955 - 2022-04-14
- FDA Inspection 1093220 - 2019-06-13
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