FDA Inspection
Carolina Liquid Chemistries Corp.Carolina Liquid Chemistries Corp. – FDA Inspection, May 12, 2017
Record Details
This FDA Inspection record concerns Carolina Liquid Chemistries Corp., with an inspection on May 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- James E. Mullally (Issuing Officer)
- Sayeeda Hdabe (Company Rep)
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ID · 3f20c396-c7cd-44a9-9ba1-046cb196bd98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012691
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Carolina Liquid Chemistries Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 27, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Carolina Liquid Chemistries Corp.
- FDA Inspection 1229202 - 2024-06-13
- FDA Inspection 1109946 - 2019-06-27
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