# FDA 483 - Pharm D Solutions, LLC - August 28, 2018

Source: https://www.keypedia.com/records/483/pharm-d-solutions-llc/f7745fff-f66b-499a-8afd-5828d13e351e

> FDA 483 for Pharm D Solutions, LLC on August 28, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharm D Solutions, LLC
- Inspection Date: 2018-08-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details multiple deficiencies observed during an inspection.

**Facility and Operations:** The inspection focused on the aseptic compounding of sterile injectable and lyophilized drug products, including Trimix, HCG, Lipo MIC-12, and Testosterone.

**Violations and Observations:**

*   **Microbiological Contamination Prevention (Repeat Observation):**
    *   Inadequate smoke studies under dynamic conditions in ISO 5 laminar air flow workbenches (LAFWs), failing to simulate routine production or verify airflow.
    *   Media fills not simulating worst-case activities or challenging aseptic operations.
    *   Numerous aseptic practice deficiencies observed: technicians blocking HEPA airflow, bare skin exposed, leaning into LAFWs, wiping LAFWs over open vials, transporting partially stoppered vials without ISO 5 protection, insufficient drying of sprayed gloves, inadequate spraying of items before introduction into LAFWs, and technicians re-entering cleanroom without re-gowning after touching non-sterile items.
    *   Use of non-pharmaceutical grade components (e.g., (b)(4) instead of (b)(4) USP) in sterile drug compounding.

*   **Quality Control Unit Deficiencies:**
    *   Failure to reject sterile drug product batches not meeting potency specifications (e.g., HCG, Lipo MIC-12 lots with out-of-spec or no potency results were released).
    *

## Related Documents

- [483 - 2015-06-05](https://www.keypedia.com/records/483/pharm-d-solutions-llc/f87a09f8-175a-48a4-ace9-a2de933ec166)
- [483 - 2018-08-28](https://www.keypedia.com/records/483/pharm-d-solutions-llc/611020a4-f5d5-4292-bc7a-7cab75fed0c7)

## Related Officers

- [Senior Director, Precision Medicine and Innovative Strategies](https://www.keypedia.com/people/tracy-k-li/dce1757a-bb2a-462c-868c-bae77168a764)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/pharm-d-solutions-llc/52029220-2ddc-456a-b5ce-35e2ea05f2a0

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c