# FDA EIR - Arbor Pharmaceuticals Inc. - October 15, 2021

Source: https://www.keypedia.com/records/eir/arbor-pharmaceuticals-inc/8a4f9c08-65c5-44c7-9fe5-a6f56ec809d3

> FDA EIR for Arbor Pharmaceuticals Inc. on October 15, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Arbor Pharmaceuticals Inc.
- Inspection Date: 2021-10-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA conducted a comprehensive postmarketing adverse drug experience (PADE) inspection of Arbor Pharmaceuticals Inc. from October 12-15, 2021, at its Atlanta, GA location. This surveillance inspection, requested by the Center for Drug Evaluation and Research (CDER) under Compliance Program 7353.001, focused on the firm's procedures for monitoring, receiving, processing, and submitting adverse events for products regulated under the Food, Drug, and Cosmetic Act. While no official FDA Form 483 (Inspectional Observations) was issued, three important discussion items were communicated to management. These included the need for Standard Operating Procedures (SOPs) to accurately reflect current processes, ensuring expedited adverse events are submitted within the required 15-day timeline (19 late submissions were identified over three years), and ensuring timely submission of periodic safety reports (one quarterly report was 35 days late). Arbor Pharmaceuticals management acknowledged these observations and demonstrated cooperation. As a corrective action, updated SOPs were provided during the inspection to better align with current procedures, and a corrective action plan was in place for the late periodic safety report. The final inspection classification will be determined by CDER.

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Company: https://www.keypedia.com/companies/arbor-pharmaceuticals-inc/9d4dc50b-048a-4b58-9e68-f1954cba3791

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c