FDA Inspection
Respitek (Pty) LtdRespitek (Pty) Ltd – FDA Inspection, Feb 11, 2016
Record Details
This FDA Inspection record concerns Respitek (Pty) Ltd, with an inspection on February 11, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Respitek (Pty) Ltd
- Inspection Date
- February 11, 2016
- Product Type
- Devices
View Company Profile
ID · 687819ea-e38a-4fc0-bdae-c481f97e43fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958327
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 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 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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