# FDA 483 - Stonegate Pharmacy LP - March 02, 2016

Source: https://www.keypedia.com/records/483/stonegate-pharmacy-lp/73e2e9c8-9fb3-4f07-b2c0-03573154a87c

> FDA 483 for Stonegate Pharmacy LP on March 02, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stonegate Pharmacy LP
- Inspection Date: 2016-03-02
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 documents observations from an inspection, identifying multiple deficiencies in the facility's operations related to sterile drug product manufacturing.

**Key Observations:**

*   **Sterilization Process Validation:** Procedures for preventing microbiological contamination lack adequate validation of the sterilization process.
*   **Media Fills:** Media fills do not accurately simulate actual production or worst-case conditions, failing to cover all operators involved in preparing injectable drug products.
*   **Environmental Monitoring:** Aseptic processing areas have deficient systems for monitoring environmental conditions.
*   **Disinfection Practices:** Non-sterile wipes are used for disinfecting the ISO 5 laminar flow hood (LFH).
*   **Personnel Gowning:** Personnel clothing is inappropriate for duties performed in drug product manufacturing.
*   **Discrepancy Investigations:** Unexplained discrepancies and batch failures are not thoroughly reviewed, even if the batch has been distributed.
*   **Container Closure Systems:** Container closure systems do not adequately protect against foreseeable external factors causing deterioration or contamination.
*   **Container/Closure Sterilization:** Drug product containers and closures are not sterilized or processed to remove pyrogenic properties.
*   **Sterility/Pyrogen Testing:** Each batch of sterile, pyrogen-free drug product is not laboratory tested for conformance to these requirements.
*   **Stability Testing:** No written program exists to assess drug product stability characteristics.
*   **Equipment Cleaning/Maintenance:** Written procedures for cleaning and

## Related Documents

- [483 - 2018-06-11](https://www.keypedia.com/records/483/stonegate-pharmacy-lp/35283892-d8f0-4a9d-89a7-dde75490ec6e)
- [483 - 2019-08-09](https://www.keypedia.com/records/483/stonegate-pharmacy-lp/c948dd31-de1a-4498-9261-c32c51948cfd)
- [STATE_REFERRAL_LETTER - 2019-08-05](https://www.keypedia.com/records/state_referral_letter/stonegate-pharmacy-lp/af0ec7c1-2736-49e1-9d9f-500d77969d52)
- [145 - 2019-04-24](https://www.keypedia.com/records/145/stonegate-pharmacy-lp/7f7c0497-2203-4b7d-ad26-44ac26532d1b)
- [STATE_REFERRAL_LETTER - 2018-05-30](https://www.keypedia.com/records/state_referral_letter/stonegate-pharmacy-lp/5358563a-6ba6-4b5b-b405-d2f394cee1cd)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/stonegate-pharmacy-lp/f7c2ae1a-3694-4030-b0f7-b37e0794a48d

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9