# FDA 483 - empower clinic services, llc,  - October 04, 2024

Source: https://www.keypedia.com/records/483/empower-clinic-services-llc/7740360b-9089-4379-9eda-f7c4904b0ce5

> FDA 483 for empower clinic services, llc,  on October 04, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: empower clinic services, llc, 
- Inspection Date: 2024-10-04
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspection of a pharmaceutical facility revealed several critical deficiencies. Observation 1 noted inadequate containment and segregation for hazardous drug production, specifically the use of the same ISO-5 filling line and laminar flow hoods for both hazardous and non-hazardous drugs without sufficient containment studies in cleaning validation to prevent cross-contamination.

Observation 2 identified difficult-to-clean surfaces in the ISO-5 cleanroom, including apparent rust on outlets. Observation 3 cited a lack of routine certification for the ISO-5 area. Observation 4 detailed failures in cleaning and disinfection, specifically the lack of scientific rationale for not sterilizing product contact surfaces like the stopper sorting bowl and supply hopper, which are only chemically disinfected.

Observation 5 highlighted deficiencies in media fills, noting that the maximum batch size challenged in media fills (e.g., 15 vials) was significantly smaller than actual production batch sizes (e.g., 600 vials). Additionally, media fills did not qualify operators for all relevant operations. Observation 7 indicated that smoke studies were inadequately performed under dynamic conditions, failing to demonstrate unidirectional airflow and assess particle control during aseptic interventions.

Finally, Observation 8 revealed the use of non-pharmaceutical grade ingredients, specifically cosmetic-grade Azelaic Acid, in the production of non-sterile drug products, with units released into interstate commerce. These observations indicate significant issues with contamination control, facility maintenance, environmental monitoring, process validation, and raw material control, impacting the quality

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## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [Investigator](https://www.keypedia.com/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.keypedia.com/companies/empower-clinic-services-llc/3c4e9f1f-9b53-408d-8a8c-4d0d20481e0c

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c