FDA Inspection
Carolina Biological Supply CoCarolina Biological Supply Co – FDA Inspection, Mar 8, 2018
Record Details
This FDA Inspection record concerns Carolina Biological Supply Co, with an inspection on March 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e846a382-00fe-4ad6-9c31-4c1714a76854
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044795
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Carolina Biological Supply Co
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2025 | NAI | Atlanta District Office | Postmarket Assurance: Medical Devices |
| September 23, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 4, 2018 | Not classified | Atlanta District Office |
Other documents for Carolina Biological Supply Co
- FDA Inspection 1295704 - 2025-12-17
- FDA Inspection 1180794 - 2022-09-23
- FDA Inspection 1047154 - 2018-04-04
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