# FDA 483 - Itc Compounding - July 23, 2019

Source: https://www.keypedia.com/records/483/itc-compounding/1ccbb544-aad3-469a-aab3-66b4b4f93bff

> 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: This FDA Form 483 document outlines several significant observations made during an inspection of a drug manufacturing facility. The facility is cited for producing highly potent drugs without adequate containment, segregation, cleaning of work surfaces, and cleaning of utensils, leading to a risk of cross-contamination. Non-microbial contamination was observed in the production area.

A critical finding is the use of a non-pharmaceutical grade component in the formulation of a drug product. Laboratory controls were found to be deficient, lacking scientifically sound and appropriate specifications, standards, sampling plans, and test procedures to assure conformity of drug product containers, in-process materials, and drug products to identity, strength, quality, and purity standards.

Regarding quality systems and personnel, employees have not received training in current Good Manufacturing Practices (GMP). Furthermore, the responsibilities and procedures for the quality control unit are not documented in writing. Finally, there are no written procedures for production and process controls designed to assure the identity, strength, quality, and purity of the drug products. These observations indicate significant deficiencies in contamination control, material quality, laboratory oversight, personnel training, and overall quality system documentation.

## Related Documents

- [483 - 2019-07-23](https://www.keypedia.com/records/483/itc-compounding/17e1d64e-d32b-449e-a963-0f69a7ac967b)
- [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