# FDA 483 - PETNET Solutions, Inc - September 23, 2016

Source: https://www.keypedia.com/records/483/petnet-solutions-inc/f502e1ae-b44d-4260-b3e5-6cc85f8f6a4f

> FDA 483 for PETNET Solutions, Inc on September 23, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PETNET Solutions, Inc
- Inspection Date: 2016-09-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of PETNET Solutions, Inc. in Royal Oak, MI, revealed that the firm's laboratory analytical methods are not sufficiently specific or accurate. Specifically, issues were noted with the software's inability to identify and integrate main peaks during FDG purity testing, leading to invalid results. This indicates a significant quality control deficiency in their analytical processes.

## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)

Company: https://www.keypedia.com/companies/petnet-solutions-inc/e3c4970d-6393-43ba-b713-1c2b03d94027

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0