# FDA WARNING_LETTER - Labotech Microscopes India Private Limited - September 12, 2013

Source: https://www.keypedia.com/records/warning_letter/labotech-microscopes-india-private-limited/c1682f25-13a1-44d6-8f98-67d2b033da81

> FDA WARNING_LETTER for Labotech Microscopes India Private Limited on September 12, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Labotech Microscopes India Private Limited
- Inspection Date: 2013-09-12
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On September 9-12, 2013, an FDA inspection of Labotech Microscopes India Private Limited in Haryana, India, revealed that their slit lamps and microscopes are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820. The firm's September 23, 2013, response to the FDA 483 was deemed inadequate.

Violations include:
1.  **Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d))**: (b)(4) out of (b)(4) Xcel 255 slit lamp testing reports showed values outside specified ranges. QSP 15, Rev. 6, lacked a mechanism for identifying non-conforming test results. The firm's response, including a revised traveler form and updated procedures, was insufficient as it did not describe a specific mechanism for identifying nonconforming product or provide evidence of evaluation for previously released Xcel 255 slit lamps with failed test results.

2.  **Failure to establish and maintain procedures for design changes (21 CFR 820.30(i))**: Design changes, such as those for the mount projection lens (Nonconformance (b)(4)) and the (b

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Gautam Aggarwal](https://www.keypedia.com/people/gautam-aggarwal/46f65c81-ed94-4a2b-9868-ecc5ef768a6f)

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Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7