# FDA 483 - Grandpa's Compounding Pharmacy, Inc. - September 10, 2013

Source: https://www.globalkeysolutions.net/records/483/grandpas-compounding-pharmacy-inc/6c00b8a4-e434-4ecf-aeab-6c7268f2b6f1

> FDA 483 for Grandpa's Compounding Pharmacy, Inc. on September 10, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grandpa's Compounding Pharmacy, Inc.
- Inspection Date: 2013-09-10
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: The FDA Form 483 details significant deficiencies in aseptic processing and quality control at a facility manufacturing sterile injectable drugs.

**Facility and Operations:** The aseptic operations are conducted within an ISO-5 horizontal airflow hood, supported by an ISO-7 area and an ISO-8 ante-room.

**Violations and Observations:**
*   **Air Handling and Cleanroom Environment:**
    *   Aseptic areas lack adequate HEPA-filtered air supply under positive pressure.
    *   No raw data supports ISO-5 classification; the hood is labeled Class 7.
    *   No records or qualification for the air handling system supplying ISO-7/8 areas.
    *   The air supply duct's HEPA filter status is unknown, and it has unsecured sections with air leakage.
    *   A small, unvalidated window-type air conditioner is used for circulation in the cleanroom, with unknown air source.
    *   Air pressure monitoring is visual (plastic curtain movement) instead of measured.
    *   No Non-Viable Particle (NVP) measurements are taken during dynamic operations.
    *   No airflow pattern (smoke study) evaluations performed for ISO-5, ISO-7, or between ISO-7/8 areas.
*   **Personnel Gowning and Aseptic Practices:**
    *   Personnel gowning (disposable smocks, covers) is non-sterile and not made of

## Related Documents

- [WARNING_LETTER - 2013-09-10](https://www.globalkeysolutions.net/records/warning_letter/grandpas-compounding-pharmacy-inc/3d69f475-d53e-4fec-9ec0-59b4a2f9b0bb)
- [483 - 2015-09-18](https://www.globalkeysolutions.net/records/483/grandpas-compounding-pharmacy-inc/739b4bdc-bd90-45d5-8bb3-b3dd101e4dab)

## Related Officers

- [Ashar P. Parikh](https://www.globalkeysolutions.net/people/ashar-p-parikh/f5430c51-31c7-44bb-90f7-1ec8ae581343)
- [Thomas J. Arista](https://www.globalkeysolutions.net/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)

Company: https://www.globalkeysolutions.net/companies/grandpas-compounding-pharmacy-inc/8d24aba0-28c1-4040-8714-9c8525fbfbbb

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df