FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Missouri Analytical Laboratories (2021)
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 a testing laboratory, where deleted data files and falsified records were found.
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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
A contract testing laboratory. FDA found about 36 deleted files or folders in a recycle bin, and said an investigation did not fully assess falsified autoclave records and other data integrity breaches.
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 Missouri Analytical Laboratories on 30 Sep 2021. 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. FDA issued a close-out letter on 9 Oct 2024.
Who and what it applies to
This one firm. It is a record of enforcement, not guidance for everyone.
What it contains
- Investigations
- Discrepancies were not thoroughly investigated.
- Computer controls
- FDA cited failure to control computer systems so that only authorised people make changes.
- What FDA asked for
- An assessment of the extent of data integrity deficiencies.
Key points
- Contract laboratories receive these letters too.
- "Working copies" was not accepted as an answer without a retrospective review.
- 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.
- Audit data integrity controls at contract laboratories, not only their results.
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 |
|---|---|---|---|
| 9 Oct 2024 | Close-out letter issued | Warning letter (closed) | Source for Close-out letter issued |
| 30 Sep 2021 | 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 9 Oct 2024
Source: FDA. Public domain.
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