# FDA 483 - Terra Pharma Labs, Inc - November 08, 2023

Source: https://www.globalkeysolutions.net/records/483/terra-pharma-labs-inc/bb989fda-3c83-46ac-ae7d-e4702490c282

> FDA 483 for Terra Pharma Labs, Inc on November 08, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terra Pharma Labs, Inc
- Inspection Date: 2023-11-08
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Terra Pharma Labs, Inc. in Irving, TX, a manufacturer of dietary supplements, revealed 12 significant observations related to fundamental deficiencies in quality control and record-keeping. The firm failed to establish product specifications, conduct raw material testing, maintain lot traceability, and implement essential written procedures for manufacturing, packaging, labeling, holding, distribution, and sanitation. These findings indicate a severe lack of adherence to regulatory requirements for dietary supplement production.

## Related Officers

- [Sara A. Valenzuela](https://www.globalkeysolutions.net/people/sara-a-valenzuela/3c52de0b-f54b-4812-a83d-597d80890fe2)
- [Denise Connelly](https://www.globalkeysolutions.net/people/denise-connelly/cb196412-348c-4f66-9347-3fdec6d2e3bc)

Company: https://www.globalkeysolutions.net/companies/terra-pharma-labs-inc/3bc54c0e-e82c-4b67-84d0-f13b2534bb2c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab