# FDA 483 - TG Labs, Inc. - September 29, 2022

Source: https://www.keypedia.com/records/483/tg-labs-inc/32d59109-bb29-4edc-b6fa-558a5da691d8

> FDA 483 for TG Labs, Inc. on September 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TG Labs, Inc.
- Inspection Date: 2022-09-29
- Product Type: drugs
- Office Name: Denver District Office
- Summary: TG Labs, Inc. in Centennial, CO, a manufacturer of Tetracycline 3% Ointment, was cited for significant deficiencies in its quality control unit, laboratory practices, and facility controls during an FDA inspection. The observations highlight issues with written procedures, record-keeping, equipment calibration, and prevention of contamination and mix-ups. Several observations were removed after discussion, indicating some resolution or clarification during the inspection.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)
- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.keypedia.com/companies/tg-labs-inc/2e2e362d-4481-47e0-912f-f745aa2741df

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face