# FDA EIR - MERCK RESEARCH LABORATORIES DIV MERCK CO INC - June 05, 2009

Source: https://www.keypedia.com/records/eir/merck-research-laboratories-div-merck-co-inc/3b78366c-9abb-4077-8011-fa1b14a7204f

> FDA EIR for MERCK RESEARCH LABORATORIES DIV MERCK CO INC on June 05, 2009. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
- Inspection Date: 2009-06-05
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Merck Research Laboratories in West Point, PA, was conducted from June 1-5, 2009, under the regulatory framework for Nonclinical Laboratories (C.P. 7348.808). The inspection covered three toxicity studies in monkeys and dogs. Investigators issued a seven-item FDA Form 483, detailing significant observations. Key violations included a lack of documentation confirming proper handling of test article suspensions during dosing for all three studies. Final study reports were found deficient as they did not include signed and dated contributions from individual scientists or professionals involved. Protocols and final reports failed to identify all automated systems used for data collection, such as for antemortem data. A critical Standard Operating Procedure (SOP SA-4053) for bioanalytical method validation was deemed inadequate due to wide acceptance limits for stability assessments, potentially compromising data accuracy. Furthermore, email correspondence related to study activities was not maintained. Lastly, the pathology data system indicated that specific tibia and lymph node samples from one study were not histopathologically examined as required. Merck's management committed to providing a written response to the Agency to address these findings, implying corrective actions are required to ensure compliance with good laboratory practices.

## Related Documents

- [EIR - 2009-06-05](https://www.keypedia.com/records/eir/merck-research-laboratories-div-merck-co-inc/02be383f-bdfe-49c1-8e5f-58e812200df7)
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Company: https://www.keypedia.com/companies/merck-research-laboratories-div-merck-co-inc/fcdc523a-3335-4327-b2dd-a984dee8efb9

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8