# FDA 483 - Itc Compounding - July 23, 2019

Source: https://www.keypedia.com/records/483/itc-compounding/17e1d64e-d32b-449e-a963-0f69a7ac967b

> FDA 483 for Itc Compounding on July 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Itc Compounding
- Inspection Date: 2019-07-23
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Infusion Treatment Center Inc dba ITC Compounding in Castle Rock, CO, revealed significant deficiencies in their production of non-sterile drugs. The firm failed to prevent cross-contamination, maintain clean production environments, and ensure the quality of components. Furthermore, there was a complete absence of adequate laboratory controls, GMP training for staff, and written procedures for quality control and production processes, indicating a severe lack of oversight and control over drug manufacturing.

## Related Documents

- [483 - 2019-07-23](https://www.keypedia.com/records/483/itc-compounding/1ccbb544-aad3-469a-aab3-66b4b4f93bff)
- [STATE_REFERRAL_LETTER - 2019-07-12](https://www.keypedia.com/records/state_referral_letter/itc-compounding/ef01c452-662d-4627-af44-02b880396a22)

## Related Officers

- [Zachary A. Bogorad](https://www.keypedia.com/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

Company: https://www.keypedia.com/companies/itc-compounding/dd623812-5320-4242-9016-42ff7be28946

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face