# FDA 483 - Imagilin Technology Llc - January 16, 2020

Source: https://www.globalkeysolutions.net/records/483/imagilin-technology-llc/3513c541-8463-4f69-b8c6-cca2013e475d

> FDA 483 for Imagilin Technology Llc on January 16, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Imagilin Technology Llc
- Inspection Date: 2020-01-16
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Imagilin Technology LLC, a manufacturer of dietary supplements, identified significant deficiencies in their manufacturing processes. The firm failed to establish and follow written master manufacturing records for their probiotic products. Additionally, Imagilin Technology LLC did not establish required product specifications for identity, purity, strength, composition, or contamination limits for their finished dietary supplements and their components.

## Related Documents

- [483 - 2023-11-09](https://www.globalkeysolutions.net/records/483/imagilin-technology-llc/3fb344ed-8299-4c05-b37d-1bcb6bcb6e53)

## Related Officers

- [company_representative](https://www.globalkeysolutions.net/people/d-patel/ba07afb6-83af-4cf4-8faf-437f0bcbce61)
- [Karen A. Spencer](https://www.globalkeysolutions.net/people/karen-a-spencer/119faf4e-25ec-4507-96c0-0f191614d720)

Company: https://www.globalkeysolutions.net/companies/imagilin-technology-llc/4c15c8b6-40cf-4f8e-b970-c0744fc9b8fe

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e
