FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Curia New York, Inc. (2026)
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 usernames and passwords for a system used for GMP analysis.
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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
FDA reported sharing of usernames and passwords for a computerised system used for GMP analysis. It asked for an independent assessment of all computerised systems, and a data integrity compliance officer able to receive anonymous concerns.
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 Curia New York, Inc. on 18 Sep 2026. It concerns active ingredients, 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
- Complete data
- Laboratory records did not include complete data.
- Quality unit
- The unit did not meet its responsibility.
- Computerised systems
- Failure to control systems against unauthorised access, including shared logins.
- What FDA asked for
- An independent assessment beyond the systems cited, and a data integrity compliance officer.
Key points
- A named system review was not enough: FDA asked for all computerised systems.
- FDA asked for a route for anonymous concerns.
- 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.
- Scope data integrity reviews to all computerised systems in CGMP use.
- Give staff a way to raise data integrity concerns safely.
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 |
|---|---|---|---|
| 18 Sep 2026 | 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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