# FDA 483 - InfuScience a subsidiary of Bioscrip - May 15, 2015

Source: https://www.keypedia.com/records/483/infuscience-a-subsidiary-of-bioscrip/dfbac2dd-0b3e-4583-95a3-0dd1a348118a

> FDA 483 for InfuScience a subsidiary of Bioscrip on May 15, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InfuScience a subsidiary of Bioscrip
- Inspection Date: 2015-05-15
- Product Type: Drugs
- Office Name: New England District Office
- Summary: This FDA Form 483 details significant deficiencies observed during an inspection of a facility producing sterile injectable drug products, including hydromorphone, penicillin-type, and beta-lactam non-penicillin drugs.

**Key Violations and Observations:**

*   **Complaint Handling:** The firm failed to follow procedures (CLIN-PH107, ADMP015) for reporting an adverse event related to hydromorphone on 11/24/14 to the Corporate Clinical Services Department, despite noting it in an electronic chart and sending a replacement.
*   **Personnel Gowning:** Cleanroom operators performing aseptic manipulations wore non-sterile gowns, caps, and face masks. Non-sterile eye protection did not fully cover the area around the eyes, leaving exposed facial skin over critical ISO 5 laminar flow areas.
*   **Environmental Monitoring:** Viable and non-viable air counts in ISO 5 zones were not performed daily during production, only during annual cleanroom certification. Work surfaces and operator gloves in ISO 5 hoods were not tested daily for microbial contamination. ISO 7 clean rooms and anterooms lacked continuous air pressure differential monitoring, with one gauge showing approximately zero inches W.G. on 05/12/15.
*   **Cleaning and Disinfection:** Non-sterile, particle-shedding wipes were used to disinfect ISO 5 hoods. Sporicidal agents were not used, and a

## Related Documents

- [STATE_REFERRAL_LETTER - 2015-05-12](https://www.keypedia.com/records/state_referral_letter/infuscience-a-subsidiary-of-bioscrip/32efb066-0193-48ce-87bf-e2c65cf3a475)

## Related Officers

- [Biomedical Engineer with experince in Diagnostics and IT, Projects and Quality Control](https://www.keypedia.com/people/carmen-y-kelly/36fa9b21-545a-4dfc-8f11-2eb23462b10c)
- [FDA Biologics Investigator](https://www.keypedia.com/people/viviana-matta/6fecf0ca-0edc-4538-a57e-72642f41b5c7)

Company: https://www.keypedia.com/companies/infuscience-a-subsidiary-of-bioscrip/49a01095-4069-49e8-b04e-817366ac0dd2

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144