# FDA EIR - 1RUWK $PHULFDQ 6FLHQFH $VVRFLDWHV  ,QF - August 16, 2018

Source: https://www.keypedia.com/records/eir/1ruwk-phulfdq-6flhqfh-vvrfldwhv-qf/5eac22b4-3c2a-4043-b7c3-4bd8509c3e29

> FDA EIR for 1RUWK $PHULFDQ 6FLHQFH $VVRFLDWHV  ,QF on August 16, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: 1RUWK $PHULFDQ 6FLHQFH $VVRFLDWHV  ,QF
- Inspection Date: 2018-08-16
- Product Type: devices
- Office Name: Food and Drug Administration
- Summary: A routine FDA inspection was conducted at North American Science Associates, Inc. (NAMSA) in Northwood, OH, from August 13 to August 16, 2018. This pre-announced inspection was performed under Compliance Program 7348.808, focusing on Good Laboratory Practice (Nonclinical Laboratories) to ensure adherence to regulatory frameworks like 21 CFR Part 58. The scope included a comprehensive review of facilities, operations, quality assurance, personnel, equipment, test article accountability, standard operating procedures, and the conduct of three specific nonclinical studies. Notably, the inspection concluded without identifying any main violations or objectionable conditions. As a result, no FDA Form 483, List of Inspectional Observations, was issued to NAMSA, and no refusals were encountered or samples collected. Consequently, no specific regulatory actions or voluntary corrections were required by the FDA following this inspection, indicating that the facility was found to be in compliance with applicable regulations.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)
- [company_representative](https://www.keypedia.com/people/mark-shumaker/52727152-7f08-4b78-894f-8a3fff8ec231)
- [company_representative](https://www.keypedia.com/people/jean-pierre-boutrand/6238b6b6-7d2b-4991-abb5-8ab5ca76ee02)
- [recipient](https://www.keypedia.com/people/john-j-gorski/7b50533f-4cb2-4ff3-83ac-fe19550a184a)
- [investigator](https://www.keypedia.com/people/marcia-a-worley/bbcc8e30-05b1-4ad4-85da-17209ace9246)

Company: https://www.keypedia.com/companies/1ruwk-phulfdq-6flhqfh-vvrfldwhv-qf/b666dff5-4e63-48a7-b900-118a876d44a9

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516