# FDA 483 - SCA Pharmaceuticals, Inc. - November 07, 2019

Source: https://www.keypedia.com/records/483/sca-pharmaceuticals-inc/d9de0613-d136-4442-8e3b-9a488253e118

> FDA 483 for SCA Pharmaceuticals, Inc. on November 07, 2019. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SCA Pharmaceuticals, Inc.
- Inspection Date: 2019-11-07
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of SCA Pharmaceuticals, Inc., an outsourcing facility located in Little Rock, AR, was conducted from October 28 to November 7, 2019. The inspection resulted in six observations detailed in a Form FDA 483, highlighting significant deficiencies related to drug manufacturing and quality control.

Key issues identified included inadequate sterility testing methods that did not meet USP <71> standards, and a failure to thoroughly investigate unexplained discrepancies, such as a confirmed potency failure for Vasopressin, without notifying customers of updated beyond-use dating. The company also lacked proper controls over computer systems, specifically failing to conduct audit trail reviews for sterility analysis software and allowing administrator access for routine tasks. Documentation for product examination was found to be insufficient, with reject products from visual inspections improperly segregated, leading to inaccurate batch records. Furthermore, SCA Pharmaceuticals was observed compounding drug products that are essentially copies of approved drugs, a violation of sections 503B(a)(5) and 503B(d)(2) of the Food, Drug, and Cosmetic Act. Lastly, employees performing sterility analysis lacked current training and recertification.

These observations indicate non-compliance with Current Good Manufacturing Practices (CGMP) and specific provisions for outsourcing facilities under the Drug Quality and Security Act. SCA Pharmaceuticals, Inc. is required to provide a comprehensive response detailing corrective and preventive actions to address each observation and ensure regulatory compliance.

## 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 - 2023-05-17](https://www.keypedia.com/records/483/sca-pharmaceuticals-inc/81934160-17f4-4812-95ec-e80afc9332a6)
- [483 - 2025-10-20](https://www.keypedia.com/records/483/sca-pharmaceuticals-inc/b241011e-ec18-43b3-ba69-6aae9c51750b)

## Related Officers

- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

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