# FDA 483 - Enemeez, LLC dba Summit Pharmaceuticals - July 29, 2021

Source: https://www.globalkeysolutions.net/records/483/enemeez-llc-dba-summit-pharmaceuticals/0344632e-4cc3-473d-bcd6-b7d7d62d6d3e

> FDA 483 for Enemeez, LLC dba Summit Pharmaceuticals on July 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enemeez, LLC dba Summit Pharmaceuticals
- Inspection Date: 2021-07-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: During an inspection, Eneemez, LLC dba Summit Pharmaceuticals, an OTC drug manufacturer, was cited for deficiencies in its stability program for mini enema drug products. Observations included a lack of specific, stability-indicating test methods and inadequate storage conditions for stability samples. The firm also failed to adhere to its written stability testing program, using improperly stored samples and switching contract laboratories without proper procedure.

## Related Officers

- [Sales Store Checker](https://www.globalkeysolutions.net/people/james-b-arnett/1d316c56-fe53-40d5-90f9-ddf04c488aa8)
- [Joel D. Hustedt](https://www.globalkeysolutions.net/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.globalkeysolutions.net/companies/enemeez-llc-dba-summit-pharmaceuticals/dd1473a2-9b40-4ff6-a713-f83d1ba98c4f

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6