# FDA 483 - Dental Technologies Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/dental-technologies-inc/b633f41b-0330-486e-a6a1-a8a2eaed5353

> FDA 483 for Dental Technologies Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dental Technologies Inc.
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Dental Technologies, Inc. received a Form 483 citing multiple deficiencies across its manufacturing and quality control operations. Key issues include inadequate sampling plans, deficient microbiological testing methods, and failures in investigating discrepancies and out-of-specification results. The firm also demonstrated shortcomings in cleaning validation, documentation practices, corrective and preventive actions, design validation, and risk analysis for both drug products and medical devices.

## Related Documents

- [EIR - 2017-06-29](https://www.keypedia.com/records/eir/dental-technologies-inc/da5608bd-d8df-4ff4-81a8-173e03776a0a)
- [WARNING_LETTER - 2021-01-20](https://www.keypedia.com/records/warning_letter/dental-technologies-inc/2eb8f341-222c-4df3-93de-1c03f5296db2)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)
- [Anders Evenson](https://www.keypedia.com/people/anders-evenson/a37224ef-88c8-47ed-83ba-421695dd2228)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.keypedia.com/companies/dental-technologies-inc/b453abbd-d2e0-40e9-9bb8-bd069643f30a

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669