# FDA 483 - Swabplus, L.P. - April 11, 2019

Source: https://www.keypedia.com/records/483/swabplus-lp/31d63ade-3ce2-4910-8b24-c85975b4212d

> FDA 483 for Swabplus, L.P. on April 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Swabplus, L.P.
- Inspection Date: 2019-04-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Genbplus, L.P. in Rancho Cucamonga, CA, a drug manufacturer, was cited for significant deficiencies across its operations, including inadequate laboratory controls, quality system failures, and issues with facilities and equipment. The inspection revealed a lack of proper component and finished product testing, unvalidated test methods, and insufficient data integrity controls. These findings indicate a broad failure to adhere to Good Manufacturing Practices.

## Related Documents

- [WARNING_LETTER - 2019-04-11](https://www.keypedia.com/records/warning_letter/swabplus-lp/5461343e-4b98-47a1-9d85-76715639c73c)
- [483 - 2021-10-15](https://www.keypedia.com/records/483/swabplus-lp/ad8ba3e4-24f5-4783-98cf-d69644ca94ff)
- [483 - 2023-08-01](https://www.keypedia.com/records/483/swabplus-lp/3d12f5d0-b45a-4b21-89e6-e817790270b0)
- [483 - 2023-08-01](https://www.keypedia.com/records/483/swabplus-lp/60af52cb-3aef-48a9-b437-ddd3bfa6196c)

## Related Officers

- [Diane R. Weidley](https://www.keypedia.com/people/diane-r-weidley/9d67f057-c980-4b7a-abaf-ae534b530662)
- [Senior Consumer Safety Officer ](https://www.keypedia.com/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)

Company: https://www.keypedia.com/companies/swabplus-lp/628a618d-9bd4-48cb-a4f5-462dfdc84b7b

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6