# FDA WARNING_LETTER - Ei LLC - October 06, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/ei-llc/b6042281-ab78-4338-b962-4b8f39501576

> FDA WARNING_LETTER for Ei LLC on October 06, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ei LLC
- Inspection Date: 2017-10-06
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA issued a Warning Letter to Product Quest MFG, LLC following an inspection of their drug manufacturing facility, Ei LLC, from October 2-6, 2017. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations, rendering their drug products adulterated.

Key violations include:
1.  **Inadequate Separate Defined Areas (21 CFR 211.42(c)):** The firm manufactured human drugs and pesticides in the same building using shared equipment, leading to cross-contamination. Records confirmed two human drugs contained a pesticide. The FDA requires a plan for dedicated equipment and an analysis of pesticide testing results in other human drugs, including a risk assessment for all drugs previously produced on shared equipment, and plans for addressing product quality and patient safety risks for products still in distribution.
2.  **Failure to Establish Adequate Cleaning Procedures (21 CFR 211.67(b)):** The firm did not adequately validate cleaning procedures to prevent cross-contamination between human drugs or between human drugs and non-pharmaceutical products. The FDA requires a comprehensive risk evaluation for all products manufactured and a detailed plan for adequate cleaning validation, including summary reports and analytical methods.
3.  **Failure to Thoroughly Investigate Discrepancies (21 CFR 211.192):** Investigations into equipment cleaning and product contamination were not thorough or timely. An investigation into an unknown impurity in erythromycin

## Related Officers

- [Ms.](https://www.globalkeysolutions.net/people/kathryn-weingart/5cf95fa4-b860-47dc-8449-b37be76dbed2)
- [Program Division Director](https://www.globalkeysolutions.net/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.globalkeysolutions.net/companies/ei-llc/88b53134-ac99-4eb2-b709-2a80a826ad7d

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9