# FDA 483 - College Pharmacy, Inc. - March 15, 2013

Source: https://www.keypedia.com/records/483/college-pharmacy-inc/c800ac48-df0c-4aa8-bda7-4cfb787bb795

> FDA 483 for College Pharmacy, Inc. on March 15, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: College Pharmacy, Inc.
- Inspection Date: 2013-03-15
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: The FDA Form 483 details numerous deficiencies at a facility engaged in aseptic processing of drug products, particularly sterile injectables.

**Facility and Operations:**
The clean room, designated ISO 5 and ISO 6, has structural modifications without continuous monitoring data to support its classification. The ISO 7 gowning room and ISO 8 formula preparation area also exhibit issues.

**Violations and Observations:**

*   **Cleanroom Classification & Monitoring:**
    *   Structural modifications to the clean room are not supported by continuous monitoring.
    *   HEPA recertification lacks leak testing and dynamic evaluations.
    *   No routine active or non-active particulate monitoring is performed outside of review.
    *   A stained HEPA filter (HEPA #5) above an ISO 5 workbench, caused by non-sterile product explosion, was not investigated.
    *   Blocked return vents near HEPA #1 and #2 lacked evaluation of impact on air currents or product.
    *   Pressure differentials are not continuously monitored between ISO 5, ISO 6, ISO 7, and ISO 8 areas. The only monitored differential (ISO 6 to ISO 7) is not continuous and reads 0.0 when the door opens.
    *   No parameters exist for door open times between classified areas.
    *   The ISO 7 to ISO 8 pressure differential is not maintained due to an unsealed wall-mounted

## Related Documents

- [483 - 2015-05-28](https://www.keypedia.com/records/483/college-pharmacy-inc/cafe21ab-6a14-48ab-bef0-e7c9b740e2f7)
- [483 - 2018-01-17](https://www.keypedia.com/records/483/college-pharmacy-inc/c6b4e51e-c0e2-41e4-b792-fdeb912624e4)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/matthew-r-dionne/cb73de54-3a7e-47c6-a7ba-a7e35e7e6c8d)
- [Supervisory microbiologist](https://www.keypedia.com/people/zachery-l-miller/e7ff2001-1e81-4483-9e9b-288b7e92c719)

Company: https://www.keypedia.com/companies/college-pharmacy-inc/332d3e4f-fb8f-4bd2-8b8a-bcb20d4c563b

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