# FDA 483 - SIWA Biotech Corp. - April 27, 2018

Source: https://www.keypedia.com/records/483/siwa-biotech-corp/0549fa73-e713-4f53-9df4-fd942ad137b0

> FDA 483 for SIWA Biotech Corp. on April 27, 2018. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SIWA Biotech Corp.
- Inspection Date: 2018-04-27
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: SIWA Biotech Corp. in Oklahoma City, OK, an In-Vitro Diagnostic (IVD) Manufacturer, was cited for significant deficiencies in quality oversight, contamination control, and procedural adherence during an FDA inspection. Observations included inadequate potency testing, delayed investigations of Out-of-Specification results, persistent microbial contamination, and a lack of essential SOPs and vendor qualifications. These issues indicate a systemic failure in maintaining proper manufacturing and quality control standards.

## Related Officers

- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [Teresita Mercado, Supervisory Biologist](https://www.keypedia.com/people/teresita-mercado-supervisory-biologist/4a16c225-9742-411c-9893-160a02941e2a)
- [Darcel Bigelow, CSO and Meihong Liu, CSO](https://www.keypedia.com/people/darcel-bigelow-cso-and-meihong-liu-cso/619b1773-6d33-49e5-909b-c66c43d2b6ae)
- [Hector Carrion, CSO](https://www.keypedia.com/people/hector-carrion-cso/be67f96c-ad15-494d-98f3-ac983d033b8c)

Company: https://www.keypedia.com/companies/siwa-biotech-corp/ed6f2e94-6dcd-4015-89da-4c06239419c1

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd