# FDA 483 - Ben Venue Laboratories, Inc. - December 02, 2011

Source: https://www.keypedia.com/records/483/ben-venue-laboratories-inc/1b82f496-b877-4bea-8213-000c0401e470

> FDA 483 for Ben Venue Laboratories, Inc. on December 02, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ben Venue Laboratories, Inc.
- Inspection Date: 2011-12-02
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details significant deficiencies at Ben Venue Laboratories (BVL) across its Quality System, manufacturing, and validation processes.

The Quality Unit demonstrated inadequate oversight, failing to approve/reject products and procedures impacting drug quality. The Corrective Action/Preventive Action (CAPA) system lacked formal CAPAs for project improvements, despite weekly "ILP Improvement Project" meetings. A "Compliance Dashboard" for tracking deviations, complaints, change controls, CAPAs, and quality protocols existed but was not integrated into the Quality System or Quality Manual.

The Change Control Program was not followed, with senior management not notified of critical deviations (e.g., 115576, a failing vial washer re-qualification) within hours, and critical designations downgraded without documented justification or notification. Investigations, such as 115576, were not initiated in a timely manner.

Routine preventative maintenance was overdue for approximately 107 GMP equipment items as of 11/11/11, with no documented Quality Unit action. An investigation was not opened for Sestamibi lot #0077-00-2055354 despite exceeding the "Percent Defects" limit.

Aseptic media fill processes were deficient: interventions were not performed by all individuals listed in the manufacturing batch record, and media-filled vials within the manual intervention "zone clearance" were discarded without scientific rationale, precluding adequate

## Related Officers

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- [Thomas J. Arista](https://www.keypedia.com/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)
- [General Manager](https://www.keypedia.com/people/michael-p-sheehan/bb91f6d2-e3fb-488f-a502-7039f556449f)
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Company: https://www.keypedia.com/companies/ben-venue-laboratories-inc/6e919084-1abf-40fd-af39-b4f480806a24

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