FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Nortec Quimica SA (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 over 100 deleted files were found on instrument computers.
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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
FDA found over 100 deleted files in recycle bins on two spectrophotometer computers, some with batch numbers in their names. It said actions must be attributable to a specific person.
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 Nortec Quimica SA on 8 Dec 2022. 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. FDA issued a close-out letter on 23 Oct 2023.
Who and what it applies to
This one firm. It is a record of enforcement, not guidance for everyone.
What it contains
- Computerised systems
- Failure to control systems against unauthorised access or changes, and to prevent omission of data.
- Quality unit
- Batch production and laboratory records were not reviewed before distribution.
- What FDA asked for
- A list of software configurations and user privileges, including administrator rights and oversight roles.
Key points
- Stand-alone instrument computers are in scope.
- Actions must be attributable to one person.
- 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.
- Include stand-alone instrument computers in your data integrity reviews.
- Check that backup covers those computers too.
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 |
|---|---|---|---|
| 23 Oct 2023 | Close-out letter issued | Warning letter (closed) | Source for Close-out letter issued |
| 8 Dec 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 23 Oct 2023
Source: FDA. Public domain.
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