# FDA 483 - Oregon Compounding Centers, Inc. - August 28, 2014

Source: https://www.keypedia.com/records/483/oregon-compounding-centers-inc/84d65c03-e54d-4254-9edf-e563bb15db5f

> FDA 483 for Oregon Compounding Centers, Inc. on August 28, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oregon Compounding Centers, Inc.
- Inspection Date: 2014-08-28
- Product Type: Drugs
- Office Name: Seattle District Office
- Summary: An FDA inspection of Oregon Compounding Centers, Inc. dba Creative Compounds, conducted from August 4 to August 28, 2014, revealed critical deficiencies in the firm's production of sterile drug products. The facility failed to establish and adhere to adequate procedures to prevent microbiological contamination, exhibiting poor aseptic techniques, improper material handling, and insufficient personnel gowning. Crucially, sterilization processes for aseptic filling, autoclave cycles for components, and filtration methods were not properly validated across all product types and batch sizes. The company also neglected to investigate drug products that failed sterility specifications and maintained an inadequate testing program, failing to conduct sterility and endotoxin testing on all batches, and performing insufficient potency testing. Furthermore, environmental monitoring, cleaning, and air handling systems in aseptic areas were found to be deficient. The firm also lacked a comprehensive stability program and supporting data for the assigned Beyond Use Dates of its sterile injectable products. Corrective actions are required to address these significant deviations from current Good Manufacturing Practices and ensure patient safety.

## Related Documents

- [WARNING_LETTER - 2014-08-28](https://www.keypedia.com/records/warning_letter/oregon-compounding-centers-inc/e0eaefb4-d00f-443f-a12a-9d334c09abf9)
- [483 - 2014-08-28](https://www.keypedia.com/records/483/oregon-compounding-centers-inc/dbbb71f1-4d9a-44fa-b577-7c241af5a2bf)
- [483_RESPONSE - 2014-08-05](https://www.keypedia.com/records/483_response/oregon-compounding-centers-inc/7b3d59a8-f468-4703-b5ef-f87eb673b62c)

## Related Officers

- [Heika R. Tait](https://www.keypedia.com/people/heika-r-tait/1239332e-3227-491a-a6dc-f80fb44f4214)
- [Senior Microbiologist](https://www.keypedia.com/people/jamie-m-du/2280342e-d14b-436c-a2df-ba87181be11e)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)
- [Compliance Officer - CDER/OC/OMQ](https://www.keypedia.com/people/anita-narula/fbebf5a2-e25c-4e98-9c22-433d9102380c)

Company: https://www.keypedia.com/companies/oregon-compounding-centers-inc/88c35e66-624f-4d5d-accf-d6ba47e259fd

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913