# FDA 483 - Swabplus, L.P. - August 01, 2023

Source: https://www.globalkeysolutions.net/records/483/swabplus-lp/60af52cb-3aef-48a9-b437-ddd3bfa6196c

> FDA 483 for Swabplus, L.P. on August 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Swabplus, L.P.
- Inspection Date: 2023-08-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Swabplus, L.P., a contract repacker in Rancho Cucamonga, CA, received an FDA Form 483 with ten observations following an inspection from July 25 to August 1, 2023. The findings reveal significant deficiencies across quality control, production processes, laboratory controls, equipment design, and facility maintenance. Repeat observations include failures in purified water system sanitization and inadequate audit trail review, indicating systemic issues with GMP compliance that pose risks to drug product quality.

## 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 - 2021-10-15](https://www.globalkeysolutions.net/records/483/swabplus-lp/ad8ba3e4-24f5-4783-98cf-d69644ca94ff)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

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