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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.
TITLE/ COMPANY | Issue Date | Status | Details |
---|---|---|---|
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Cohance Lifesciences Limited |
12 Aug 2025 | Normal | Justification: Directly linked to the unlogged complaints in Field Alert Report Log, violating SOP requirements. Excerpt: Complaint investigations that are involved with field alert reporting activities are not logged into the Field Alert Report Log. View Details |
Written records of investigation of a drug complaint do not include the follow-up. Cohance Lifesciences Limited |
12 Aug 2025 | Normal | Justification: The absence of communication and potential failure to file required Field Alert Reports indicates process lapses. Excerpt: SOP QA084-02, Field Alert Report... However, there is no documented explanation... View Details |
A Field Alert Report was not submitted within three working days of receipt Aurolige Pharma LLC |
10 Apr 2025 | Normal | Justification: The issue directly relates to the Field Alert Report process as the observation cites failure to submit FAR timely. Excerpt: Your firm failed to submit a Field Alert Report (FAR) to the agency within three (3) working days. View Details |
Responsibilities and procedures for quality units are not in writing and/or followed to ensure the FARS (BPDR) are submitted Janssen Vaccines Corporation |
19 Nov 2024 | Normal | Justification: The issue involves failure to submit FARs despite multiple complaints of the same defect. Proper execution of Field Alert Report procedures ensures compliance with FDA reporting regulations. Excerpt: You failed to follow your procedure, TV-WI-21853 Version 29.0 Product Quality Complaint Investigation (Effective date 5/25/2024) Section 7.11.1.2 that sets the requirement for FAR (BPDR). View Details |
Reserve samples from representative sample lots or batches of drug products GlaxoSmithKline Biologicals |
12 Mar 2024 | Normal | Justification: Delayed reporting of adverse drug experiences relates specifically to the Field Alert Report process. Excerpt: Eighty-four (84) 15-Day Alert reports were reported late (after 15 days) for Shingrix Vaccine. View Details |
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