FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Landy International (2024)
Warning letter 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 staff shared a password kept in a drawer, on a system with no audit trail.
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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
In plain English
A stand-alone gas chromatograph lacked an audit trail and individual logins. Staff used a shared password kept in an unsecured drawer.
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 Landy International on 12 Jun 2024. 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.
Who and what it applies to
This one firm. It is a record of enforcement, not guidance for everyone.
What it contains
- Testing
- Batches and components were not adequately tested.
- Process control
- Written procedures were not adequate.
- Computer controls
- No audit trail or individual logins, and a shared password.
- Interim controls
- FDA asked how data would be protected before fixes were complete.
Key points
- Shared passwords are a recurring finding.
- FDA asks about interim controls, not only final fixes.
- 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.
- Plan interim controls for systems waiting on an upgrade.
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 |
|---|---|---|---|
| 12 Jun 2024 | Warning letter issued | Warning letter | Source for Warning letter issued |
Official source
The official text always prevails over anything on this site.
FDA's list shows no close-out letter for this warning letter.
Source: FDA. Public domain.
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