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FDA Inspection
•Carolina Precision Technologies•June 27, 2016

Carolina Precision Technologies – FDA Inspection, Jun 27, 2016

Record Details

This FDA Inspection record concerns Carolina Precision Technologies, with an inspection on June 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company
Carolina Precision Technologies
Inspection Date
June 27, 2016
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 7055ed10-071e-48fe-a63a-c3576588e383

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
976029
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  2. 21 CFR 820.22Quality Audits - defined intervals
  3. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Carolina Precision Technologies

3
DateClassificationOfficeProject area
June 27, 2025Not classifiedNew England District Office
May 28, 2025NAICenter for Devices and Radiological HealthCompliance: Devices
February 11, 2020VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Carolina Precision Technologies
  • FDA Inspection 1275637 - 2025-06-27
  • FDA Inspection 1274635 - 2025-05-28
  • FDA Inspection 1117518 - 2020-02-11

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