FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Allay Pharmaceuticals (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 one firm, which did not assess the risk of having no audit trail controls and unique user passwords.
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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
The firm did not assess the risk of running without audit trail controls and unique user passwords.
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 Allay Pharmaceuticals on 27 Jan 2021. 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 18 Jul 2022.
Who and what it applies to
This one firm. It is a record of enforcement, not guidance for everyone.
What it contains
- Production and process control
- Written procedures were not adequate.
- Investigations
- Unexplained discrepancies and failures were not thoroughly investigated.
- Stability
- The testing program was not adequate.
- Quality unit
- The unit did not meet its responsibilities, including assessing the risk from missing audit trail controls and shared passwords.
Key points
- Missing audit trails and unique passwords are a risk to assess, not only a gap to fix.
- 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.
- Record a risk assessment for any system without audit trail or unique login controls.
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 Jul 2022 | Close-out letter issued | Warning letter (closed) | Source for Close-out letter issued |
| 27 Jan 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 18 Jul 2022
Source: FDA. Public domain.
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