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FDA Inspection
•Xiantao Zhongtai Protective Products Co.,Ltd•August 1, 2019

Xiantao Zhongtai Protective Products Co.,Ltd – FDA Inspection, Aug 1, 2019

Record Details

This FDA Inspection record concerns Xiantao Zhongtai Protective Products Co.,Ltd, with an inspection on August 1, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Xiantao Zhongtai Protective Products Co.,Ltd
Inspection Date
August 1, 2019
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · eb8dcc8f-b700-452e-ad74-ae48eef43e15

Inspection Facts

Inspection number
1098902
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 820.150Lack of or inadequate procedures for storage.
  2. 21 CFR 820.22Quality audits - Lack of or inadequate procedures
  3. 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
  4. 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule

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