# FDA 483 - SCA Pharmaceuticals, LLC - October 20, 2023

Source: https://www.keypedia.com/records/483/sca-pharmaceuticals-llc/c1c62ce7-3030-4d95-9666-6515e7ee4830

> FDA 483 for SCA Pharmaceuticals, LLC on October 20, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SCA Pharmaceuticals, LLC
- Inspection Date: 2023-10-20
- Product Type: Drugs
- Office Name: New England District Office
- Summary: The FDA Form 483 inspection revealed significant deficiencies at the facility, primarily concerning quality control, manufacturing processes, and documentation.

**Quality Control Unit Deficiencies:**
*   No dedicated quality control unit.
*   Investigation process for particulates is deficient; no requirement to identify particulates or open investigations after 100% visual inspection failures, even when AQL fails or after a second 100% inspection failure.
*   Visual inspection SOP (ILP-001-W) does not trigger retraining after AQL failures post-100% inspection.
*   Production employees, not Quality, perform AQL and tightened AQL.

**Manufacturing and Production Issues:**
*   Visual inspection yield is not calculated or established in batch records (e.g., Hydromorphone HCL 1mg/mL, Fentanyl 50mcg/mL, Hydromorphone HCL 0.2 mg/mL batches showed significant yield variations).
*   Failure to thoroughly review unexplained discrepancies and batch failures.
    *   SOP TM 008 allows product release without investigation after Test Method 1 (Light Obscuration) failure if Test Method 2 (Microscopic) passes.
    *   Inadequate investigation and remediation of 29 in-house sterility OOS results, particularly for spore-forming microbes (e.g., Phenylephrine HCl lot 12230

## 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 - 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)
- [483 - 2018-03-05](https://www.keypedia.com/records/483/sca-pharmaceuticals-llc/462a285a-3e2c-4cb1-8b9a-c1afdef8ce82)

## Related Officers

- [Regional Manager](https://www.keypedia.com/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)
- [Arizona Market President](https://www.keypedia.com/people/john-p-mistler/7b2d423d-46cc-48bd-aa5a-4ae794888060)

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