FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Laboratorios Jaloma S.A. de C.V. (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, for incomplete laboratory records and weak controls over changes to computer data.
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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
Laboratory records lacked complete data, and FDA cited computer controls. It said the response had no gap analysis of data integrity controls that allow unauthorised changes or deletion.
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 Laboratorios Jaloma S.A. de C.V. on 22 May 2026. 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
- Complete data
- Laboratory records did not include complete data from all tests.
- Laboratory controls
- Specifications, standards and procedures were not adequate.
- Computer controls
- FDA cited failure to control computer systems so that only authorised people make changes.
- Quality unit
- The unit did not meet its responsibilities.
Key points
- FDA expected a gap analysis of data integrity controls.
- 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.
- Run a gap analysis of controls that allow change or deletion of 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 |
|---|---|---|---|
| 22 May 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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