# FDA 483 - MasterPharm LLC - May 06, 2015

Source: https://www.keypedia.com/records/483/masterpharm-llc/79454088-dfe6-4c5e-bf8b-de15484e9df4

> FDA 483 for MasterPharm LLC on May 06, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MasterPharm LLC
- Inspection Date: 2015-05-06
- Product Type: Drugs
- Office Name: New York District Office
- Summary: The FDA Form 483 inspection identified multiple deficiencies at the facility related to aseptic processing, environmental control, and quality systems.

**Aseptic Processing Deficiencies:**
*   **Smoke Studies:** Not performed under dynamic conditions for ISO 5 non-hazardous, ISO 7 hazardous, and ISO 5 within ISO 7 clean rooms to verify airflow unidirectionality.
*   **Clutter:** Observed on an ISO 5 workstation during processing of Morphine/Bupivacaine/Clonidine Intrathecal syringe lot 04-22-2015:53, including plastic bins with alcohol wipes or paper records.

**Environmental Monitoring Deficiencies:**
*   **Viable Air Counts:** Not performed daily in ISO 5 zones during production; last monitored on 10/29/14 during cleanroom certification.
*   **Non-Viable Particulates:** Not performed under dynamic conditions in ISO 5 zones; last monitored on 10/29/14 during cleanroom certification.
*   **Work Surface Testing:** ISO 5 hood surfaces not tested daily for microbial contamination during production or at end of operations.
*   **Pressure Differentials:** Not continuously monitored during production for ISO 5 non-hazardous, ISO 7 hazardous clean rooms, and their respective anterooms.

**Cleaning and Disinfection Deficiencies:**
*   **Sporicidal Agents:** Not

## Related Documents

- [483 - 2017-01-30](https://www.keypedia.com/records/483/masterpharm-llc/c0680046-cbeb-4ef9-90e6-98d5db128ac2)
- [STATE_REFERRAL_LETTER - 2017-01-17](https://www.keypedia.com/records/state_referral_letter/masterpharm-llc/9609a69c-1cc3-4779-9302-f19b15955812)
- [483 - 2020-06-15](https://www.keypedia.com/records/483/masterpharm-llc/d0bc1619-08bc-4362-b6f0-873017cf0e54)
- [483 - 2020-06-15](https://www.keypedia.com/records/483/masterpharm-llc/c0057302-3430-4733-9681-57641dc63756)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/james-a-liubicich/31b3dad6-b187-458c-8f13-dcf9a758a28b)

Company: https://www.keypedia.com/companies/masterpharm-llc/b5a31eae-f18d-4f02-a43e-f9e1a2046982

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d