# FDA 483 - SCA Pharmaceuticals, Inc. - May 17, 2023

Source: https://www.keypedia.com/records/483/sca-pharmaceuticals-inc/81934160-17f4-4812-95ec-e80afc9332a6

> FDA 483 for SCA Pharmaceuticals, Inc. on May 17, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SCA Pharmaceuticals, Inc.
- Inspection Date: 2023-05-17
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA inspection of an unnamed facility revealed significant deficiencies in aseptic processing areas and quality control.

**Environmental Monitoring Deficiencies:**
*   The firm lacks a scientifically sound environmental monitoring plan, including appropriate sampling frequency and timing.
*   Documentation does not demonstrate representative environmental sampling.
*   Viable active air samples are taken infrequently (e.g., one per four hours or lot, with discretion on timing).
*   Continuous non-viable particle monitoring in ISO 5 Laminar Flow Hoods is not activated until after critical connections, omitting earlier activities like vial preparation and admixing.

**Air Supply and Cleanroom Design Issues:**
*   ISO 7 Cleanroom 902, where critical operations occur, has issues with its ISO 5 Laminar Flow Hoods (Hood #s (b)(4)).
*   Certification reports for these hoods (dated (b)(4) and (b)(4)) lack measurements of unidirectional air velocity near the work surface.
*   Air return vents in Room 902 are frequently obstructed by items like carts, tables, and trash receptacles, as demonstrated by a July 6-7, 2022 smoke study and observed during inspection.

**Failure to Investigate Discrepancies:**
*   The firm failed to thoroughly review unexplained discrepancies.
*   On May 3 and May 5, 2023, environmental monitoring plates for passive air monitoring in ISO

## Related Documents

- [483 - 2014-04-01](https://www.keypedia.com/records/483/sca-pharmaceuticals-inc/bebda7d8-bc7f-4e1e-936d-e4c84617ff8a)
- [483 - 2017-09-29](https://www.keypedia.com/records/483/sca-pharmaceuticals-inc/5831d7f5-785d-463c-bae7-4147c44b70f4)
- [483 - 2019-11-07](https://www.keypedia.com/records/483/sca-pharmaceuticals-inc/d9de0613-d136-4442-8e3b-9a488253e118)
- [483 - 2025-10-20](https://www.keypedia.com/records/483/sca-pharmaceuticals-inc/b241011e-ec18-43b3-ba69-6aae9c51750b)

## Related Officers

- [ CSO](https://www.keypedia.com/people/megan-t-ziegler/3e83a317-701a-4e40-bb43-34d294d3448f)
- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/sca-pharmaceuticals-inc/2ef86fd7-d7d9-4bed-9ad6-24594b9b1f94

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9