# 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/8b58efae-b873-423d-83f3-899a7c8d2f5b

> 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: Dallas District Office
- Summary: From March 1 to March 10, 2022, the FDA inspected North American Custom Laboratories, LLC, dba FarmaKeio Superior Custom Compounding, located at 1736 N Greenville Ave, Richardson, TX 75081-1808. The facility produces sterile and non-sterile drug products. Robert A. Harris, Director of Business Development / Facility Manager, was the individual to whom the report was issued.

The inspection revealed eight observations:

1.  **Non-pharmaceutical grade sterile water for injection (WFI) was used for sterilization and compounding.** Specifically, non-pharmaceutical grade WFI was used to sterilize Sermorelin Acetate 1mg/ml (Lot #34585) and to reconstitute CJC-1295 Acetate/Ipamorelin Acetate Injection (Lot #34383). Inadequate filter integrity tests were conducted, and drug products were distributed nationwide.
2.  **Materials and supplies were not disinfected prior to entering aseptic processing areas.** A plastic tote containing sterile tubing, vials, and stoppers was not disinfected when placed in the ISO8 non-sterile compounding room or when introduced into the ISO5 buffer room or ISO5 LAFH.
3.  **Non-sterilized equipment was used in sterile drug production.** Non-sterile scissors and a handheld crimper were wiped with sterile alcohol and used

## Related Documents

- [483 - 2022-03-10](https://www.keypedia.com/records/483/north-american-custom-laboratories-llc-dba-farmakeio-superior-custom-compounding/00daecea-cbf1-44b9-b82a-651c9bc82949)
- [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/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9