# FDA 483 - Giles Chemical - July 27, 2022

Source: https://www.keypedia.com/records/483/giles-chemical/c0214e2b-be17-4bff-b659-186a25a012fd

> FDA 483 for Giles Chemical on July 27, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Giles Chemical
- Inspection Date: 2022-07-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Giles Chemical, a division of Premier Magnesium LLC, a bulk Magnesium Sulfate manufacturer in Greendale, IN, was cited for significant quality system deficiencies. Observations include a lack of established critical process parameters, inadequate raw material release procedures, absence of microbiological testing, and poor facility sanitation. The firm also failed to properly investigate complaints, implement preventative maintenance, and ensure correct product labeling before shipment.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Rebecca Barth](https://www.keypedia.com/people/rebecca-barth/eca3e8ef-b3c4-4930-94b6-0e8648301dbd)

Company: https://www.keypedia.com/companies/giles-chemical/7541d032-00cd-4285-91e7-b149d23a1db2

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