FDA Inspection
Terrific Care LlcTerrific Care Llc – FDA Inspection, Feb 5, 2019
Record Details
This FDA Inspection record concerns Terrific Care Llc, with an inspection on February 5, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a4445925-9910-45b5-aca8-6a3ae4de04bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078169
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Terrific Care Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Terrific Care Llc
- FDA Inspection 1143601 - 2021-05-27
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