# FDA 483 - TG Labs LLC - October 29, 2021

Source: https://www.globalkeysolutions.net/records/483/tg-labs-llc/6860f947-50d0-4f77-ac34-60cce51f3ff3

> FDA 483 for TG Labs LLC on October 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TG Labs LLC
- Inspection Date: 2021-10-29
- Product Type: drugs
- Office Name: Denver District Office
- Summary: TG Labs LLC, a drug manufacturer in Centennial, CO, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across quality control, production, and laboratory operations, indicating a systemic lack of documented procedures, investigations, and proper record-keeping for drug product manufacturing and release. These issues suggest a moderate to severe level of non-compliance with good manufacturing practices.

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Company: https://www.globalkeysolutions.net/companies/tg-labs-llc/fae18fad-d75f-4a97-b0b9-323e95727921

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