FDA Inspection
Carolina Biological Supply CoCarolina Biological Supply Co – FDA Inspection, Sep 23, 2022
Record Details
This FDA Inspection record concerns Carolina Biological Supply Co, with an inspection on September 23, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 23, 2022
- Product Type
- Devices
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ID · d3882b25-66f2-4158-a32d-c9ef68d4b3c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1180794
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| April 4, 2018 | Not classified | Atlanta District Office | |
| March 8, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Carolina Biological Supply Co
- FDA Inspection 1295704 - 2025-12-17
- FDA Inspection 1047154 - 2018-04-04
- FDA Inspection 1044795 - 2018-03-08
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