# FDA 483 - IntegraDose Compounding Services LLC - September 19, 2018

Source: https://www.keypedia.com/records/483/integradose-compounding-services-llc/37962bbd-499c-4159-897f-8284e6c1d6e6

> FDA 483 for IntegraDose Compounding Services LLC on September 19, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IntegraDose Compounding Services LLC
- Inspection Date: 2018-09-19
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: The FDA Form 483 details multiple observations regarding a pharmaceutical facility's quality control and manufacturing practices.

**Key Violations and Observations:**

*   **Inadequate Out-of-Specification (OOS) Investigations:** The firm failed to thoroughly investigate OOS results for several drug products, releasing batches based solely on retesting without identifying a laboratory error or root cause.
    *   **Ephedrine Sulfate 25mg/5mL Syringe (Lot 20180228EPH-1):** Released despite a positive (b)(4) result (indicating possible microbiological contamination) without adequate sterility failure investigation.
    *   **Hydromorphone Syringes (Multiple Lots):** Several lots (20171025HYD-1, 20171219HYD-1, 20180123HYD-2, 20180329HYD-2, 20180531HYD-1) were released with potency results outside specifications (e.g., 132.6%, 135.9%, 136.7%, 130.1%, 127.9%, 127.8%, 94.8%, 93.8%, 93.6%, 106.

## Related Documents

- [WARNING_LETTER - 2018-09-19](https://www.keypedia.com/records/warning_letter/integradose-compounding-services-llc/2141c5b6-d4b5-4ae5-940f-261a36791d15)
- [483 - 2021-08-02](https://www.keypedia.com/records/483/integradose-compounding-services-llc/9fdc6791-8f5b-4856-8cac-92c808b1172e)
- [483 - 2024-03-01](https://www.keypedia.com/records/483/integradose-compounding-services-llc/e4ee016b-c079-4445-b32b-18f235d21304)
- [483 - 2025-07-25](https://www.keypedia.com/records/483/integradose-compounding-services-llc/3aa397e8-0c21-48cf-94fb-9cc29da7d9af)

## Related Officers

- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

Company: https://www.keypedia.com/companies/integradose-compounding-services-llc/8035ad8c-1993-4ab6-bb81-f3094a178eac

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03