FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Lex Inc. (2023)
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 laboratory staff held administrator rights and data changes could not be traced.
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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
Some laboratory staff had administrator rights allowing uncontrolled deletion or changes to HPLC files, and the firm could not trace who deleted or changed data.
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 Lex Inc. on 17 Aug 2023. 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
- Quality unit
- The unit did not meet its responsibilities.
- Components and process control
- Testing and procedures were not adequate.
- Equipment
- Automatic, mechanical or electronic equipment was not routinely checked under a written program.
- Access
- Administrator rights were not controlled, and changes could not be traced.
Key points
- Laboratory users should not hold administrator rights without control.
- Traceability of changes is expected.
- 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.
- Separate administrator rights from people who generate data.
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 |
|---|---|---|---|
| 17 Aug 2023 | 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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