# FDA 483 - Eden's Answers Inc - August 14, 2019

Source: https://www.globalkeysolutions.net/records/483/edens-answers-inc/0a3b33b2-552f-47e6-8bdd-c50643a55701

> FDA 483 for Eden's Answers Inc on August 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eden's Answers Inc
- Inspection Date: 2019-08-14
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Edel's Answers Inc., an OTC drug manufacturer in Millersburg, OH, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of an adequate quality control unit, absence of drug product specifications and stability data, insufficient employee training, and inadequate equipment calibration and cleaning procedures. These issues indicate a broad failure to adhere to current Good Manufacturing Practices.

## Related Officers

- [Program Analyst](https://www.globalkeysolutions.net/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)

Company: https://www.globalkeysolutions.net/companies/edens-answers-inc/d550e914-d430-43df-8e6d-a087e298c416

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