# FDA 483 - United Exchange Corporation - December 19, 2019

Source: https://www.globalkeysolutions.net/records/483/united-exchange-corporation/05b3e2da-5915-47da-9b7c-70a327abac62

> FDA 483 for United Exchange Corporation on December 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Exchange Corporation
- Inspection Date: 2019-12-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: United Exchange Corporation, a distributor/corporate office in Cypress, CA, was cited for significant deficiencies in its quality control processes for drug products. The firm released eye drops that did not conform to final specifications for active ingredient strength and preservative levels, and failed to ensure appropriate laboratory testing prior to distribution. Additionally, laboratory controls were found inadequate, lacking validated testing methods and proper procedures for contract lab operations.

## 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 - 2019-12-04](https://www.globalkeysolutions.net/records/483/united-exchange-corporation/d5c23582-7d61-4520-9bc2-3f6fb80c1532)

## 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