# FDA 483 - Swabplus, L.P. - October 15, 2021

Source: https://www.globalkeysolutions.net/records/483/swabplus-lp/ad8ba3e4-24f5-4783-98cf-d69644ca94ff

> FDA 483 for Swabplus, L.P. on October 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Swabplus, L.P.
- Inspection Date: 2021-10-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Swabplus, L.P. in Rancho Cucamonga, CA, a drug manufacturer, was cited for numerous deficiencies across its manufacturing and quality systems. The inspection revealed a lack of adequate procedures and controls for water systems, computer systems, equipment cleaning validation, test method validation, laboratory controls, supplier qualification, change management, and process validation. These issues indicate a broad failure to ensure the quality, purity, and strength of their drug products.

## Related Documents

- [483 - 2019-04-11](https://www.globalkeysolutions.net/records/483/swabplus-lp/31d63ade-3ce2-4910-8b24-c85975b4212d)
- [WARNING_LETTER - 2019-04-11](https://www.globalkeysolutions.net/records/warning_letter/swabplus-lp/5461343e-4b98-47a1-9d85-76715639c73c)
- [483 - 2023-08-01](https://www.globalkeysolutions.net/records/483/swabplus-lp/60af52cb-3aef-48a9-b437-ddd3bfa6196c)

## Related Officers

- [Carolina D. Vasquez](https://www.globalkeysolutions.net/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)
- [Uttaniti Limchumroon](https://www.globalkeysolutions.net/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

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

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