# FDA EIR - Maha Ahmad, M.D. - August 13, 2021

Source: https://www.keypedia.com/records/eir/maha-ahmad-md/2035793e-177f-4fb7-b18f-bb90f8bcb7b8

> FDA EIR for Maha Ahmad, M.D. on August 13, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Maha Ahmad, M.D.
- Inspection Date: 2021-08-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA surveillance inspection was conducted on clinical investigator Maha Ahmad, M.D., operating in conjunction with Clinilabs Drug Development Corporation, from August 9 to August 13, 2021. This initial inspection focused on study conduct for an investigational new drug (IND 128789) protocol, governed by the Food, Drug, and Cosmetic Act and the Compliance Program for Clinical Investigators (7348.811). The inspection reviewed various aspects of the clinical trial, including subject eligibility, informed consent, and investigational product control. Several record discrepancies were noted. These included the enrollment of two subjects despite initially not meeting inclusion criteria, which personnel attributed to subject unfamiliarity with a 24-hour time reporting system. Further issues involved inconsistencies between source and background records for PK collection times and specific visit data, as well as a medical history item appearing in source records but not in background documentation. The site also lacked current access to the Electronic Data Capture system for complete data verification, and limited documentation was available for investigational product shipments, with only return shipping records provided. During the close-out meeting, these identified discrepancies were discussed with Dr. Ahmad and her management team. Crucially, the inspection concluded without the issuance of an FDA Form 483 (Inspectional Observations), indicating that the observed conditions did not meet the threshold for formal objectionable findings requiring immediate corrective action under regulatory standards. No formal warnings or enforcement actions were issued. The inspection report will be reviewed and classified by the Center for Drug Evaluation and Research.

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Company: https://www.keypedia.com/companies/maha-ahmad-md/1410fbab-516a-4cbe-b1de-ced3aa7a0bbf

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