# FDA EIR - Chartwell Pharmaceuticals LLC - November 01, 2016

Source: https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-llc/10f0c1e9-8bf5-4caf-9779-dad27ca98df7

> FDA EIR for Chartwell Pharmaceuticals LLC on November 01, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Chartwell Pharmaceuticals LLC
- Inspection Date: 2016-11-01
- Product Type: Drugs
- Office Name: Office of Compliance
- Summary: An FDA inspection of Chartwell Pharmaceuticals LLC and Chartwell Life Sciences LLC, conducted from October 27 to November 1, 2016, identified significant non-compliance with post-marketing adverse drug experience (ADE) reporting requirements. The inspection, guided by 21 CFR 314.80(c)(1)(i) and FDA's Post Marketing Adverse Drug Experience Reporting Inspections framework, revealed that the company failed to report serious and unexpected ADEs to the FDA within the mandated 15-calendar day timeframe. The core issue was an incorrect interpretation of the "aware date," where Chartwell considered the date it was notified by its distributors as the start of the reporting clock, rather than the actual date the distributor first received the adverse event information. This led to systemic delays in submitting crucial safety data to the FDA, as evidenced by multiple cited case reports. Additionally, deficiencies were noted in the reconciliation activities between Chartwell, its pharmacovigilance provider, and marketing partners, which were not consistently performed or adequately documented. Chartwell's management committed to providing a written response within 15 days. Required actions include correcting the "aware date" definition, updating written procedures and agreements to ensure timely reporting and consistent reconciliation processes, and investigating late reports to implement corrective and preventive measures.

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## Related Officers

- [Director, Team Biologics Staff](https://www.keypedia.com/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)
- [company_representative](https://www.keypedia.com/people/kimberly-a-ezdebski/be201024-152e-4f54-ac07-5a233630c8f3)

Company: https://www.keypedia.com/companies/chartwell-pharmaceuticals-llc/4a8c4844-be98-403a-8cb5-5fc90d592679

Office: https://www.keypedia.com/offices/office-of-compliance/d6cb6d9a-dc29-4722-9ba6-783ba341d981