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FDA Inspection
•Xiantao Tongda Non-woven Products Co., Ltd.•July 25, 2015

Xiantao Tongda Non-woven Products Co., Ltd. – FDA Inspection, Jul 25, 2015

Record Details

This FDA Inspection record concerns Xiantao Tongda Non-woven Products Co., Ltd., with an inspection on July 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
Xiantao Tongda Non-woven Products Co., Ltd.
Inspection Date
July 25, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · db8cefa5-8f32-499c-9482-f00b6c3e10fa

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
937657
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

7
  1. 21 CFR 820.70(f)Buildings
  2. 21 CFR 820.70(g)Equipment design and installation
  3. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  4. 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
  5. 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
  6. 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
  7. 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.

Full citation text and observation details available on the Dashboard.

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