# FDA 483 - Boston Analytical, Inc. - November 09, 2012

Source: https://www.keypedia.com/records/483/boston-analytical-inc/53642e2a-eb7c-47d7-b46c-68d89265485f

> FDA 483 for Boston Analytical, Inc. on November 09, 2012. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston Analytical, Inc.
- Inspection Date: 2012-11-09
- Office Name: New England District Office
- Summary: The FDA Form 483 details multiple violations of production and process control procedures, laboratory controls, and quality system requirements.

**Key Violations and Observations:**

*   **Failure to Follow Laboratory Investigation Policy (SOP P-1050, Version 16):**
    *   For Monosodium Glutamate (Project # (b)(4), Sample # (b)(4)), an OOS result of 78.46% was not investigated. The analyst re-assayed using an unapproved step, reporting 99.84%.
    *   For L-aspartic Monosodium Salt (Project # (b)(4), Sample # (b)(4)), an inconclusive identification test result was not investigated. The analyst increased concentration using an unapproved procedure, re-analyzed, and reported 99.84%. The Certificate of Analysis (C of A) did not indicate a retest.
    *   Testing into compliance without scientific justification was observed for Levofloxacin (Project Number (b)(4), Sample # (b)(4)), where OOS results on 10/06/11 led to three tests, with the third analytical findings reported on the C of A.

*   **Inadequate Sample Log-In Procedures (SOP P-110, Version 12):** The SOP does not require logging all samples upon receipt. Samples were

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Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144