# FDA 483 - North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding - March 10, 2022

Source: https://www.keypedia.com/records/483/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding/00daecea-cbf1-44b9-b82a-651c9bc82949

> FDA 483 for North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding on March 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Inspection Date: 2022-03-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding in Richardson, TX, revealed significant deficiencies in both sterile and non-sterile drug production. Observations included the use of non-pharmaceutical grade materials, inadequate aseptic processing controls, microbial contamination, and insufficient process validation, indicating serious risks to product quality and patient safety.

## Related Documents

- [483 - 2022-03-10](https://www.keypedia.com/records/483/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding/8b58efae-b873-423d-83f3-899a7c8d2f5b)
- [WARNING_LETTER - 2022-03-10](https://www.keypedia.com/records/warning_letter/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding/931b5611-1845-4df3-ae30-8f31c1caeec1)
- [483 - 2025-08-25](https://www.keypedia.com/records/483/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding/995a7772-4983-4c4f-a50e-6bed1bd98b33)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding/7c4b92d9-254c-4973-a722-4afe9513f3d6

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