# FDA 483 - alexander infusion llc  - August 01, 2016

Source: https://www.keypedia.com/records/483/alexander-infusion-llc/a4c48d76-d940-4fa8-b4be-98b8c9cefce0

> FDA 483 for alexander infusion llc  on August 01, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: alexander infusion llc 
- Inspection Date: 2016-08-01
- Product Type: Drugs
- Office Name: New York District Office
- Summary: This FDA Form 483 details observations from an inspection, highlighting multiple deficiencies in aseptic processing and quality control.

**Facility and Operations:** The inspection concerns a facility producing sterile preparations, including drug products processed in ISO 7 clean rooms and ISO 5 laminar flow hoods.

**Violations and Observations:**

1.  **Aseptic Processing Area Control:** Smoke studies are deficient, not conducted under dynamic conditions or mimicking challenging preparations to verify unidirectional airflow in ISO 7 and ISO 5 areas.
2.  **Stability Testing:** No written stability program exists to support expiration dates for sterile preparations, and potency testing has never been performed.
3.  **Personnel Gowning:** Non-sterile gowns are used for sterile preparations. An operator was observed with exposed head, facial skin, shoulders, and arms in an ISO 5 hood while wearing non-sterile attire. Sterile sleeves are still lacking for gowns in the (b)(4) Room, a repeat deficiency.
4.  **Environmental Monitoring:**
    *   Personnel fingertip sampling is not conducted at least daily during operations.
    *   Viable air counts in ISO 5 areas are not performed daily during production.
    *   Work surfaces inside ISO 5 hoods are not tested for microbial contamination daily during and at the end of operations.
5.  **Sterility Testing:**
    *   Sterility testing uses a (b)(4) with incorrect incubation temperature ((b)(

## Related Officers

- [Jenny Xiradakis](https://www.keypedia.com/people/jenny-xiradakis/c5c71309-9df4-4a9f-8c9f-671d9f63bf4f)
- [Demitria Xiradakis](https://www.keypedia.com/people/demitria-xiradakis/f5513905-9be1-49af-865f-2bc14c192f77)

Company: https://www.keypedia.com/companies/alexander-infusion-llc/e4924611-9f25-40a3-a92f-1a9d834d2bdf

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d