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

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