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Field Alert Report
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product Sun Pharmaceutical Industries Limited |
15 Dec 2023 | Normal | Justification: The issue specifically relates to the failure to submit necessary Field Alert Reports as mandated by both FDA regulations and internal SOPs, evidencing a direct linkage to the Field Alert Report process type. Excerpt: "An (b) (4) -Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product." View Details |
| failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications Dr. Reddy's Laboratories Ltd. |
27 Oct 2023 | Normal | Justification: The delay in filing the Field Alert Reports and improper closure without proper evaluation highlights a critical gap in the Field Alert Report handling process. Excerpt: The firm initiated a separate OOS investigation and filed a Field Alert on 25-Jan-2021 to the agency. View Details |
| Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required Samsung Bioepis Co., Ltd. |
15 Sep 2023 | Normal | Justification: The observation pertains to the delay in submission of post marketing 15-day alert reports, directly tying it to the Field Alert Report process type. Excerpt: Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required. View Details |
| An Field Alert Report was not submitted within of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application. Cipla Limited |
17 Feb 2023 | Normal | Justification: The observation explicitly mentions the failure to submit the Field Alert Report as per SOP 1035-G-0014, highlighting a direct issue with the Field Alert Report process. Excerpt: Quality Unit failed to submit a Field Alert Report (FAR) as required under SOP (b) (4) (1035-G-0014, Version: 7.0), "Field Alert Report" for complaints received. View Details |
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