# FDA 483 - SCA Pharmaceuticals, LLC - March 05, 2018

Source: https://www.keypedia.com/records/483/sca-pharmaceuticals-llc/462a285a-3e2c-4cb1-8b9a-c1afdef8ce82

> FDA 483 for SCA Pharmaceuticals, LLC on March 05, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SCA Pharmaceuticals, LLC
- Inspection Date: 2018-03-05
- Product Type: Drugs
- Office Name: New England District Office
- Summary: The FDA Form 483 details multiple deficiencies observed during an inspection of a drug manufacturing facility.

**Facility and Operations:** The facility compounds sterile drug products, including Rocuronium Bromide, Labetalol HCl, Hydromorphone, and Fentanyl syringes. Operations involve ISO 5 Laminar Air Flow Hoods (LAFHs), ISO 7 Compounding Rooms, and ISO 8 areas.

**Violations and Observations:**

*   **Stability Program and Testing:** The written stability program lacks reliable test methods. Specifically, the 90-day Beyond Use Date (BUD) for Rocuronium Bromide 10mg/ml 5ml syringes is unsupported by valid stability data. A contract laboratory used an inappropriate test method, measuring Bromide instead of the active ingredient Rocuronium, for lots manufactured and released between 11/27/2018 and 01/12/2018. The firm failed to investigate or risk assess the impact of this invalid method.
*   **Sterilization Process Validation:** The sterilization process lacks adequate validation. The system for qualifying environmental conditions in ISO 5 LAFHs does not assess airflow patterns under dynamic conditions for all equipment and component configurations. Dynamic smoke studies were not conducted for all relevant setups.
*   **Aseptic Technique:** Multiple instances of poor aseptic technique were observed during sterile drug compounding:
    *   Compounding technician blocking

## Related Documents

- [483 - 2026-03-13](https://www.keypedia.com/records/483/sca-pharmaceuticals-llc/533852b8-79c3-4c51-9975-9beb8bbc8681)
- [483_RESPONSE - 2023-10-20](https://www.keypedia.com/records/483_response/sca-pharmaceuticals-llc/910fa2fc-9042-43cb-a938-e5d86530779c)
- [483 - 2023-10-20](https://www.keypedia.com/records/483/sca-pharmaceuticals-llc/c1c62ce7-3030-4d95-9666-6515e7ee4830)
- [483 - 2018-03-05](https://www.keypedia.com/records/483/sca-pharmaceuticals-llc/d3c6490e-8854-4e53-87fc-e8309f4c6e8b)
- [483 - 2019-11-19](https://www.keypedia.com/records/483/sca-pharmaceuticals-llc/28023242-cae6-4ced-8d1a-def7147b5aa2)

## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)
- [Regulatory Officer I n ve s tig ato r ](https://www.keypedia.com/people/dien-nguyen/90e26f94-e417-4c64-ab44-3674387b82b4)

Company: https://www.keypedia.com/companies/sca-pharmaceuticals-llc/96e2ad34-fa1e-4fb7-a281-1aeff351cecc

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