FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Ultra Seal Corporation (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, whose laboratory audit trails showed deleted and aborted work with no recorded reason.
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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, for Ultra Seal Corporation FEI 1317759
In plain English
HPLC audit trails showed actions such as deleted methods, aborted runs, deleted manual integrations and stopped data acquisition, with no documented purpose.
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 Ultra Seal Corporation on 14 Mar 2022. 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. FDA issued a close-out letter on 25 Sep 2024.
Who and what it applies to
This one firm. It is a record of enforcement, not guidance for everyone.
What it contains
- Computer controls
- FDA cited failure to control computer systems so that only authorised people make changes.
- Audit trails
- Actions in HPLC audit trails had no documented purpose.
- What FDA asked for
- A list of instruments and software with audit trails active, user privileges up to administrator rights, and a retrospective review of manual integration events.
Key points
- Audit trail entries need a documented reason.
- FDA asked for an inventory of systems and privileges.
- 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.
- Check that deleted or aborted runs in your audit trails have a recorded reason.
- Keep a current list of instruments, audit trail status and administrator rights.
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 |
|---|---|---|---|
| 25 Sep 2024 | Close-out letter issued, for Ultra Seal Corporation FEI 1317759 | Warning letter (closed) | Source for Close-out letter issued, for Ultra Seal Corporation FEI 1317759 |
| 14 Mar 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 25 Sep 2024
Source: FDA. Public domain.
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