FDA 483 & Warning Letters: Understanding Inspection Results
Feb 18, 2025 · Learn about FDA 483s and warning letters, their implications, and examples. Understand the inspection process and how to respond effectively.
Medtronic, Inc. - 617539 - 12/09/2021 | FDA
The specific deficiencies noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s ...
Cipla Limited - 660904 - 11/17/2023 | FDA
Nov 21, 2023 · The intent of the 21 CFR 314.81 (b) (1) regulation is to establish an early warning system so that significant problems are brought to the FDA’s attention by applicant holders in order to ...
Stokes Healthcare Inc. dba Epicur Pharma - 677624 - 04/02 ...
Oct 22, 2024 · Your written notification should refer to the Warning Letter Number above (WL #677624). Please address your reply to: CAPT Liatte Closs, Acting Director of Compliance, …
How to Effectively Respond to FDA Form 483 and Warning Letters
Dec 27, 2024 · FDA Form 483 & Warning Letters address compliance issues, and regulatory violations found during inspections requiring corrective actions.
OII FOIA Electronic Reading Room | FDA
For other OII documents, please visit the OII home page and the FDA Warning Letter page. For other inspection and related records, please search the relevant center reading room page on the main ...
EpiCare Acquisitions, LLC - 702493 - 03/21/2025 | FDA
Apr 8, 2025 · The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's ...