# FDA 483 - Perceptive Informatics LLC - October 04, 2013

Source: https://www.globalkeysolutions.net/records/483/perceptive-informatics-llc/295702c3-8af6-4eb1-9e72-e510b48cfef9

> FDA 483 for Perceptive Informatics LLC on October 04, 2013. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Perceptive Informatics LLC
- Inspection Date: 2013-10-04
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Perceptive Informatics, Inc. in Billerica, MA, conducted from September 26 to October 4, 2013, identified a significant issue. The firm failed to ensure a study was conducted in accordance with its protocol and investigational plan. This involved conducting data reviews that were not prescribed by the Independent Review Charter and project plan.

## Related Documents

- [483 - 2012-02-23](https://www.globalkeysolutions.net/records/483/perceptive-informatics-llc/64e6b8f7-c624-49ed-a52c-ceef350926db)

## Related Officers

- [Darin S. Wiegers](https://www.globalkeysolutions.net/people/darin-s-wiegers/5bf03f8b-1571-4845-916d-3211d72d97a2)

Company: https://www.globalkeysolutions.net/companies/perceptive-informatics-llc/ef10b6aa-4cfc-469b-9017-389917aa871f

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7