FDA Inspection
Synergy Health Suzhou Sterilization Technologies LtdSynergy Health Suzhou Sterilization Technologies Ltd – FDA Inspection, May 22, 2014
Record Details
This FDA Inspection record concerns Synergy Health Suzhou Sterilization Technologies Ltd, with an inspection on May 22, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 22, 2014
- Product Type
- Devices
View Company Profile
ID · 1f643a99-90f2-4e6a-8437-8ac9f5b2208a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 885935
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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