# FDA 483 - Terrain Pharmaceuticals - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/terrain-pharmaceuticals/a3d1ca47-7279-47ba-874e-de4bd5c9bb96

> FDA 483 for Terrain Pharmaceuticals on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terrain Pharmaceuticals
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Terrain Pharmaceuticals in Reno, NV, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including a failure to investigate out-of-specification stability results, inadequate statistical quality control criteria and method validation, deficiencies in batch production and control records related to labeling, and insufficient GMP training for employees. These findings indicate a lack of robust quality systems and oversight in critical manufacturing and quality control processes.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.globalkeysolutions.net/companies/terrain-pharmaceuticals/1d02b2ff-2293-41b4-9a7b-da086e6ccee6

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b