# FDA 483 - Amerisource Health Services LLC - June 15, 2017

Source: https://www.keypedia.com/records/483/amerisource-health-services-llc/09f4f1d3-0c1e-43c1-a68d-eaf7e0e2d1ee

> FDA 483 for Amerisource Health Services LLC on June 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amerisource Health Services LLC
- Inspection Date: 2017-06-15
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: ASource Health Services, a repackager/packager in Columbus, OH, was cited for multiple procedural deviations during an FDA inspection. Observations included failures to follow procedures for complaint handling and investigations, environmental monitoring, and change control. These issues indicate a lack of adherence to established quality system requirements, leading to overdue investigations and unapproved repeat testing.

## Related Documents

- [EIR - 2017-06-15](https://www.keypedia.com/records/eir/amerisource-health-services-llc/07dbb3bf-fdd4-4ef5-aa34-e7e06f232d48)
- [EIR - 2022-05-27](https://www.keypedia.com/records/eir/amerisource-health-services-llc/3dee4e48-6665-409a-be18-a682029c10ca)

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)
- [Andrew J. Barrowcliff](https://www.keypedia.com/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)

Company: https://www.keypedia.com/companies/amerisource-health-services-llc/3b4ce21c-bb2a-4e93-982f-001277d5ba7a

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22