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

Source: https://www.keypedia.com/records/483/oregon-compounding-centers-inc/dbbb71f1-4d9a-44fa-b577-7c241af5a2bf

> 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: This FDA Form 483 details ten observations from an inspection of a facility manufacturing sterile injectable drug products.

**Facility and Operations:** The facility produces sterile injectable drug products, including Alprostadil/Lidocaine, Methylcobalamin, Glutathione, Calcium Gluconate, Sodium Phosphate, Selenium, MSM, Ascorbic Acid, Mitomycin, and Avastin. Operations involve ISO 5 hoods, ISO 7, and ISO 8 areas, with processes including sterile filtration, filling into various vial sizes (1mL to 100mL), syringe-to-syringe transfers, and filling from beakers using a pump.

**Violations and Observations:**

1.  **Aseptic Techniques:** Inadequate aseptic techniques were observed, including handling non-sterile components in an ISO 5 hood without disinfection, touching non-sterile materials with sterile gloves, and re-using non-sterile items. An operator also used an incompatible filter, causing product leakage, and introduced a new filter into the ISO 5 hood without sanitization.
2.  **Sterilization Process Validation:** The high-risk process simulation testing (media fills) did not cover all aseptic filling operations, including various vial sizes (30, 50, 100mL) that are sterilized in-house, syringe-to-syringe transfers, and filling from beakers with a pump. Moist heat sterilization (autoclave) for stoppers and term

## Related Documents

- [483 - 2014-08-28](https://www.keypedia.com/records/483/oregon-compounding-centers-inc/84d65c03-e54d-4254-9edf-e563bb15db5f)
- [WARNING_LETTER - 2014-08-28](https://www.keypedia.com/records/warning_letter/oregon-compounding-centers-inc/e0eaefb4-d00f-443f-a12a-9d334c09abf9)
- [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)
- [Compliance Officer - CDER/OC/OMQ](https://www.keypedia.com/people/anita-narula/fbebf5a2-e25c-4e98-9c22-433d9102380c)
- [Chemist](https://www.keypedia.com/people/eileen-microbiologist/fe7fcea3-cda9-4385-9355-eba1ac18c9a1)

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