FDA Inspection
Labotech Microscopes India Private LimitedLabotech Microscopes India Private Limited – FDA Inspection, Sep 12, 2013
Record Details
This FDA Inspection record concerns Labotech Microscopes India Private Limited, with an inspection on September 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 12, 2013
- Product Type
- Devices
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ID · 603628ba-fb74-45d0-bedd-76b5b2c3de45
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 850945
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Labotech Microscopes India Private Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2026 | Not classified | Office of Inspections and Investigations | |
| October 9, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 29, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Labotech Microscopes India Private Limited
- FDA Inspection 1332856 - 2026-07-30
- FDA Inspection 1119002 - 2019-10-09
- FDA Inspection 947143 - 2015-07-10
- FDA Inspection 715553 - 2010-12-29
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