FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Chromatography Institute of America (2025)
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 a testing laboratory, for weak laboratory controls and computer system vulnerabilities it had not assessed.
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- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
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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 contract laboratory. FDA said the response did not assess computerised system vulnerabilities that may have affected data integrity. The firm said it would create individual logins and look at audit trail technology.
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 Chromatography Institute of America on 20 Aug 2025. It concerns contract testing, 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
- Laboratory control
- Control mechanisms were not adequate.
- Investigations
- Investigations were not adequate.
- Quality unit
- Oversight was not adequate.
- What FDA asked for
- Software lists, user privileges, and audit trail procedures and status.
Key points
- Contract laboratories receive these letters too.
- FDA asks for an assessment, not only a plan to buy software.
- 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.
- Assess vulnerabilities before and alongside any system purchase.
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 |
|---|---|---|---|
| 20 Aug 2025 | 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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