FDA Inspection
ProTom International Holding CorporationProTom International Holding Corporation – FDA Inspection, Dec 14, 2021
Record Details
This FDA Inspection record concerns ProTom International Holding Corporation, with an inspection on December 14, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 14, 2021
- Product Type
- Devices
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ID · a9312db3-321f-4231-9d37-511673cc2a57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1158787
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.20(c)Management review dates
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.10Failure to submit, distinct marking
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