Sivshree Medittex (India) Pvt. Ltd. – FDA Inspection, Aug 6, 2019

Record Details

This FDA Inspection record concerns Sivshree Medittex (India) Pvt. Ltd., with an inspection on August 6, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Sivshree Medittex (India) Pvt. Ltd.
Inspection Date: August 6, 2019
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Paul M. Kawamoto (Company Rep)

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ID · aa72f897-9bba-4866-a5d1-fa98abcafe33

Inspection Facts

Inspection number: 1098731
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.17Lack of Written MDR Procedures
21 CFR 820.50(b)Supplier notification of changes
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

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FDA Inspection

Sivshree Medittex (India) Pvt. Ltd.August 6, 2019