# FDA 483 - JMA Partners - April 20, 2018

Source: https://www.keypedia.com/records/483/jma-partners/d4151ad6-01a4-4c23-af0f-9ff5f1a54e27

> FDA 483 for JMA Partners on April 20, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JMA Partners
- Inspection Date: 2018-04-20
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Guardian Pharmacy Services in Dallas, TX, a producer of sterile and non-sterile drug products, was conducted from April 2-20, 2018. The inspection revealed 15 observations regarding deficiencies in their manufacturing and quality control systems.

Key observations include:
- **Environmental Monitoring:** Aseptic processing areas lacked adequate environmental monitoring. Personnel and ISO 5 surface sampling, required monthly, had not been conducted since December 28, 2017. Semi-annual recertification of ISO 5 hoods, ISO 7 buffer room, and ISO 8 anteroom had not occurred since June 28, 2017. This was a repeat observation.
- **Cleaning and Disinfection:** Deficiencies were noted in the system for cleaning and disinfecting aseptic processing areas and equipment. Cleaning records from January 1, 2018, through April 13, 2018, were unavailable.
- **Air Recirculation:** Air was recirculated to production areas without adequate dust control. Air visualization pattern testing (smoke studies) for ISO 5 laminar airflow hoods was not documented to ensure unidirectional airflow and proper air recirculation.
- **Equipment Design and Maintenance:** An ISO 5 laminar airflow workbench had a non-stainless steel work surface bordered with non-porous particle board, which was not easily cleanable and a potential source of contamination. This was a repeat observation.

## Related Documents

- [483 - 2016-10-21](https://www.keypedia.com/records/483/jma-partners/d5936d7b-d57f-4efd-99cb-d21af4c315f8)
- [WARNING_LETTER - 2016-10-21](https://www.keypedia.com/records/warning_letter/jma-partners/9a227981-99dd-4a3e-98d3-cbbd4cb0b937)
- [483_RESPONSE - 2016-10-21](https://www.keypedia.com/records/483_response/jma-partners/3c0ff8aa-b814-4b9d-844f-682d71d2d759)
- [483 - 2018-04-20](https://www.keypedia.com/records/483/jma-partners/a704a0b8-e5b2-4743-9858-8a8a2164b732)
- [483_RESPONSE - 2018-05-14](https://www.keypedia.com/records/483_response/jma-partners/6b8ba704-fd41-4550-996f-dbfa2ff683f8)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Branch Chief](https://www.keypedia.com/people/lori-g-cantin/cb8a63cb-1a73-4fdd-878c-03b05df9d7a7)
- [Director of Inspection Readiness](https://www.keypedia.com/people/bonita-s-chester/cc6ce6f4-bb5c-452a-820c-3339361bc8b2)

Company: https://www.keypedia.com/companies/jma-partners/412b6773-4c98-4648-81f9-67dcdde0a216

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9