# FDA 483 - Everest Life Sciences LLC - February 18, 2011

Source: https://www.keypedia.com/records/483/everest-life-sciences-llc/b9037723-dd31-4862-afc6-900984e2d868

> FDA 483 for Everest Life Sciences LLC on February 18, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Everest Life Sciences LLC
- Inspection Date: 2011-02-18
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: This FDA Form 483 was issued to Jacobus Pharmaceutical Co., Inc., an Active Pharmaceutical Ingredient and Finished Dosage Form Manufacturer located in Plainsboro, NJ, following an inspection from January 24 to February 18, 2011.

The inspection revealed ten observations:

1.  **Inadequate Stability Program for Drug Products:** The written stability program for Dapsone 25 mg and 100 mg tablets lacks a stability-indicating method to monitor potential impurities.
2.  **Insufficient API Stability Testing:** The stability testing program does not evaluate Dapsone drug substance for impurities during stability testing.
3.  **Quality Unit Deficiencies:** The quality unit is not adequately involved in quality-related matters. It failed to review deviations from specifications or procedures and did not assess the need for corrective actions. This includes uninvestigated temperature/humidity excursions in stability chambers and cold rooms (e.g., CRT chamber excursions from August 2009 to January 2011, in-process cold room excursions in March-April and July-August 2010), and high-temperature excursions during transport of PASER granules (e.g., June-July 2009, February-March 2010, June-July 2010). There is no SOP for monitoring and maintenance of stability chambers and cold rooms. Deviations during 4-Aminosalicylic Acid (

## Related Documents

- [483_RESPONSE - 2011-02-18](https://www.keypedia.com/records/483_response/everest-life-sciences-llc/a6843c30-76b2-4d3d-9098-b27caef010dc)
- [483 - 2012-04-16](https://www.keypedia.com/records/483/everest-life-sciences-llc/ddc07e87-b096-4ee8-9419-c9e0b41216ab)
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- [Regulatory Affairs](https://www.keypedia.com/people/atul-j-agrawal/7c9fab5d-a13f-4217-a6fc-9dfc0bbbd555)

Company: https://www.keypedia.com/companies/everest-life-sciences-llc/3f0de21d-b48b-4f8a-a8a2-3b6e376528f4

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