# FDA 483 - BioScrip Pharmacy (NY), Inc. - September 19, 2014

Source: https://www.keypedia.com/records/483/bioscrip-pharmacy-ny-inc/011757a7-0ac8-40b5-8f3f-2e59a513ec57

> FDA 483 for BioScrip Pharmacy (NY), Inc. on September 19, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioScrip Pharmacy (NY), Inc.
- Inspection Date: 2014-09-19
- Product Type: Drugs
- Office Name: New York District Office
- Summary: The FDA Form 483 details significant deficiencies in aseptic processing, environmental control, and quality systems at a drug product manufacturing facility.

**Aseptic Processing Deficiencies:**
*   **Airflow and Pressure:** Smoke studies were not performed dynamically in ISO 7 clean rooms to verify unidirectional airflow in ISO 5 hoods/biological safety cabinet. Air pressure differentials in ISO 7 clean rooms, anteroom, and surrounding areas are not continuously monitored. A semi-annual certification on 1/06/14 showed the non-hazardous (IV mix room) differential pressure at -0.007, below the 0.02-0.05 limit, with no investigation.
*   **Operator Practices:** An operator placed non-sterile glove outer wrapping and a non-sterile cloth wipe onto an ISO 5 working surface during sterile drug processing.
*   **Personnel Gowning:** Operators wore non-sterile gowns, glasses/goggles, footwear, facial masks, and bonnets. Their faces and necks were not fully covered, exposing skin and hair over critical ISO 5 laminar flow areas.

**Environmental Monitoring Deficiencies:**
*   **Viable Air Counts:** Not performed daily in ISO 5 zones; only semi-annually (last on 7/01/14).
*   **Non-Viable Particulates:** Not performed under dynamic conditions in ISO 5 zones (last on 7/

## Related Documents

- [STATE_REFERRAL_LETTER - 2014-09-10](https://www.keypedia.com/records/state_referral_letter/bioscrip-pharmacy-ny-inc/af1ec013-d8f0-40bb-9c5a-846ef26b213b)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/james-a-liubicich/31b3dad6-b187-458c-8f13-dcf9a758a28b)

Company: https://www.keypedia.com/companies/bioscrip-pharmacy-ny-inc/c399cc62-ee77-4fef-bb91-abbc04a9a66e

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