FDA Inspection
Caldon Biotech Inc.Caldon Biotech Inc. – FDA Inspection, Jun 10, 2014
Record Details
This FDA Inspection record concerns Caldon Biotech Inc., with an inspection on June 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Caldon Biotech Inc.
- Inspection Date
- June 10, 2014
- Product Type
- Devices
View Company Profile
ID · f1d1e7bc-0782-4d6b-a694-2d7bcd56bf94
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 882649
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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