FDA Inspection
ELITE SURGICAL SUPPLIES (PTY) LTDELITE SURGICAL SUPPLIES (PTY) LTD – FDA Inspection, Mar 24, 2017
Record Details
This FDA Inspection record concerns ELITE SURGICAL SUPPLIES (PTY) LTD, with an inspection on March 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e93d8a71-fb8c-4581-8391-5f77decf7537
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007582
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.100(b)Documentation
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