FDA Inspection
Mb Industria Cirurgica LtdaMb Industria Cirurgica Ltda – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns Mb Industria Cirurgica Ltda, with an inspection on March 16, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Mb Industria Cirurgica Ltda
- Inspection Date
- March 16, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8a61f7b2-49cc-44c9-8540-272cead426ce
Inspection Facts
- Inspection number
- 1005019
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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