# FDA 483 - United Exchange Corporation - December 04, 2019

Source: https://www.globalkeysolutions.net/records/483/united-exchange-corporation/d5c23582-7d61-4520-9bc2-3f6fb80c1532

> FDA 483 for United Exchange Corporation on December 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Exchange Corporation
- Inspection Date: 2019-12-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of United Exchange Corporation, a distributor in Cypress, CA, revealed significant deficiencies across its operations. The firm lacks adequate written procedures for its quality control unit, fails to properly investigate product complaints, and has not established reliable supplier qualifications or sufficient finished product specifications and sampling plans. These issues indicate a systemic failure in ensuring the quality and purity of drug products.

## Related Documents

- [EIR - 2018-02-14](https://www.globalkeysolutions.net/records/eir/united-exchange-corporation/351a790e-086d-4438-93f2-2d4c6a038dac)
- [483 - 2018-02-14](https://www.globalkeysolutions.net/records/483/united-exchange-corporation/2f1a6f2d-6cdc-4a5f-9086-f5fc440b7f3a)
- [WARNING_LETTER - 2018-04-06](https://www.globalkeysolutions.net/records/warning_letter/united-exchange-corporation/836568c1-3466-4928-8604-a3bf0649a6e6)
- [483 - 2019-12-19](https://www.globalkeysolutions.net/records/483/united-exchange-corporation/05b3e2da-5915-47da-9b7c-70a327abac62)

## Related Officers

- [Pharmaceutical investigator](https://www.globalkeysolutions.net/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.globalkeysolutions.net/companies/united-exchange-corporation/5565fe37-7bdd-4783-9d61-1ee9ba0c97ba

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