FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Vi-Jon, LLC (2022)
Warning letter (closed) CSV & Data Integrity · Enforcement Last verified: not yet
- Issued by
- FDA
- Category
- CSV & Data Integrity
- Sub Category
- Enforcement
- Legal weight
- Warning letter: a flag, not a rule
- Reuse
- Public domain
An FDA warning letter to one firm, where deleted files were found on a computer and audit trails were not reviewed before batch release.
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Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Warning letter issued
- Close-out letter issued
In plain English
An employee opened a computer recycle bin during the inspection and found deleted files, some with names like product formulas. The quality unit did not review HPLC audit trails before batch release.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
FDA issued this warning letter to Vi-Jon, LLC on 31 Mar 2022. It concerns finished drugs, and it is listed here because of what it says about computerised systems or data integrity. FDA warning letters are public, and this one names the firm. It concerns one firm at one point in time, and it says nothing about the firm today or about other firms. FDA issued a close-out letter on 8 Mar 2024.
Who and what it applies to
This one firm. It is a record of enforcement, not guidance for everyone.
What it contains
- Computer controls
- FDA cited failure to control computer systems so that only authorised people make changes.
- Deleted files
- Deleted files and folders were found in a computer recycle bin.
- Audit trail review
- Audit trails were reviewed periodically, not before batch release.
Key points
- Recycle bins are looked at during inspections.
- Audit trail review before batch release was the issue here.
- It binds one firm, and it shows how FDA applies existing rules.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Set when audit trails are reviewed relative to batch release.
- Restrict deletion rights on laboratory computers.
Read from the source document on 2 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 8 Mar 2024 | Close-out letter issued | Warning letter (closed) | Source for Close-out letter issued |
| 31 Mar 2022 | Warning letter issued | Warning letter | Source for Warning letter issued |
Official sources
The official text always prevails over anything on this site.
- Warning letter Read the official text
- Close-out letter Read the official text 8 Mar 2024
Source: FDA. Public domain.
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