FDA · Life Science & Pharma: GxP - CSV & Data Integrity
FDA warning letter to Intas Pharmaceuticals Limited (2023)
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, where original records were destroyed and electronic batch records could be changed.
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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
Investigators found torn original CGMP documents and records destroyed with acid. Electronic batch records allowed changes to manual entries before saving, and QA did not review audit trails during batch record review. FDA said senior managers failed to ensure reliable data.
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 Intas Pharmaceuticals Limited on 28 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.
Who and what it applies to
This one firm. It is a record of enforcement, not guidance for everyone.
What it contains
- Paper records
- Original documents were torn or destroyed.
- Electronic batch records
- Manual entries could be changed before saving, including a recorded time.
- Laboratory data
- Chromatograms were reprocessed without approval, and sequences were aborted.
- Management
- FDA said senior managers did not exercise their responsibility.
Key points
- Electronic batch records are in scope, not only laboratory systems.
- Management is held responsible for data reliability.
- 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.
- Include audit trails in batch record review where entries can be changed.
- Include paper and electronic records together in data integrity checks.
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 |
|---|---|---|---|
| 28 Jul 2023 | 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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