# FDA 483 - Mikart LLC - January 18, 2019

Source: https://www.globalkeysolutions.net/records/483/mikart-llc/083276aa-5966-4ca6-ac7f-63dcab62052b

> FDA 483 for Mikart LLC on January 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mikart LLC
- Inspection Date: 2019-01-18
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Mikart Inc, a drug manufacturer in Atlanta, GA, was cited for two significant issues during an FDA inspection. Observations included failures to properly quarantine incoming raw materials according to standard operating procedures and insufficient frequency of cGMP training for packaging operators and mechanics. These conditions indicate a lack of adherence to established procedures and regulatory requirements.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rachael-l-cook/294a8276-4e31-4d9f-8f2d-6c8f08cefd06)
- [investigator](https://www.globalkeysolutions.net/people/steven-j-rush/339b831e-88b6-4b1e-b29a-d8d3ff883ca0)

Company: https://www.globalkeysolutions.net/companies/mikart-llc/f3303e07-0f87-4b83-a44d-0be8653c97bf

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7