FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Medgel Private Limited (2023)
Warning letter (closed) Data Integrity · Enforcement Last verified: not yet
- Issued by
- FDA
- Category
- 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 raw humidity data was not backed up and was deleted every month.
How to read this page
- The line under the title explains in plain words what this item is for. The coloured label beside its status gives its Category, its main subject, and Sub Category, the type of document, in the same colours as the maps.
- Status comes from the latest dated event below, and each event links to its source.
- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
- In plain English is our own summary, not the official text. Where we have read the document in detail, a fuller profile follows, with its context, scope, contents and key points.
- Related shows links to other documents. Select Compare to see two side by side.
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
Humidity raw data was not backed up and was deleted every month, so investigators could not review parts of it. FDA said corrective actions were limited to the examples it noted.
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 Medgel Private Limited on 20 Jul 2023. 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 22 May 2025.
Who and what it applies to
This one firm. It is a record of enforcement, not guidance for everyone.
What it contains
- Investigations
- Unexplained discrepancies were not thoroughly investigated.
- Quality unit
- The unit did not meet its responsibilities, including over data.
- Raw data
- Humidity data was not backed up, and was deleted monthly.
- Scope of response
- FDA said the actions did not extend to a full review of documentation, laboratory and data integrity systems.
Key points
- Environmental monitoring data is GMP data.
- A response limited to cited examples was not enough.
- 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 retention of data from environmental and utility systems.
- Extend corrective actions beyond the examples an inspector found.
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 2025 | Close-out letter issued | Warning letter (closed) | Source for Close-out letter issued |
| 20 Jul 2023 | 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 22 May 2025
Source: FDA. Public domain.
Stay updated
Newsletter signup opens at launch.