# FDA 483 - Diamondback Drugs of Delaware, LLC - May 17, 2013

Source: https://www.keypedia.com/records/483/diamondback-drugs-of-delaware-llc/debbc101-bb5d-4076-874e-54e0ec9a820b

> FDA 483 for Diamondback Drugs of Delaware, LLC on May 17, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diamondback Drugs of Delaware, LLC
- Inspection Date: 2013-05-17
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details significant deficiencies at a facility producing sterile drug products, including Buprenorphine HCl vials.

**Environmental Monitoring and Aseptic Processing Deficiencies:**
*   **Lack of Active Monitoring:** No active viable or non-viable particulate air monitoring during aseptic processing in ISO 5 hoods or ISO 7 cleanrooms. Monitoring is only conducted statically by an outside contractor.
*   **Pressure Differential Monitoring:** No active monitoring of cleanroom pressure differentials during processing; gauges are absent or unread.
*   **Personnel Monitoring:** No post-shift monitoring of personnel gloves or arms in ISO 5 hoods.
*   **Insufficient Frequency:** Environmental monitoring of ISO 5 hood and ISO 7 cleanroom surfaces is conducted infrequently by an outside contractor.

**Sterilization Process Validation and Control Issues:**
*   **Inadequate Media Fills:** Media fills do not represent actual production conditions (duration, batch size, environmental details).
*   **Out-of-Specification Certification:** An ante-room exceeded non-viable particulate specifications during certification but was still certified without re-sampling.
*   **Lack of Smoke Studies:** No recording of smoke studies for ISO 5 hoods, and no smoke studies performed in ISO 7 cleanrooms.
*   **Sterilization Process Validation:** No (b)(4) testing for the sterilizing step of drug products like Buprenorphine HCl.
*   **Component Ster

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