# FDA 483 - Expert Compounding Pharmacy - March 04, 2022

Source: https://www.keypedia.com/records/483/expert-compounding-pharmacy/4dd8e2d2-f89d-4393-8926-e7cd4292c018

> FDA 483 for Expert Compounding Pharmacy on March 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Expert Compounding Pharmacy
- Inspection Date: 2022-03-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Expert Compounding Pharmacy in Lake Balboa, CA, a producer of non-sterile drugs, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate cleaning procedures leading to cross-contamination of hormone drugs, widespread non-microbial contamination in production areas, and the use of non-pharmaceutical grade components without proper testing. Furthermore, the firm failed to perform essential quality control testing on both finished drug products and incoming raw materials, and maintained deficient batch production records lacking critical manufacturing details.

## Related Documents

- [483 - 2022-03-04](https://www.keypedia.com/records/483/expert-compounding-pharmacy/1adccd05-70c1-49d4-8068-cc0b6bf4bf53)
- [UNTITLED_LETTER - 2022-08-26](https://www.keypedia.com/records/untitled_letter/expert-compounding-pharmacy/2d63d772-a5dd-4321-912c-1a894e604970)
- [483 - 2022-03-04](https://www.keypedia.com/records/483/expert-compounding-pharmacy/fb11102f-0110-4785-af26-949166a62b18)

## Related Officers

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

Company: https://www.keypedia.com/companies/expert-compounding-pharmacy/b8189258-476a-4c84-95d7-5de0e4ce5452

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