FDA 483 OBSERVATION · #68 OF 1,923 MOST-CITED
Batch record - complete
FDA cited this observation 367 times across 288 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
Batch production and control records were not complete — required entries (actual results, in-process controls, performed-by/checked-by signatures, deviations) were missing, so the record did not fully document the manufacture and control of the batch.
Why FDA writes it — The batch record is the evidence that a batch was made under control and per the master record. An incomplete batch record means the firm cannot demonstrate the batch was properly manufactured, tested, and controlled — undermining its release.
- Prepare a batch production and control record for each batch, including complete information relating to the production and control of each batch.
- Document actual performance of each significant step, including dates, identities of major equipment and lines, specific identification of each batch of component, actual results, and in-process/laboratory control results.
- Record who performed and who checked or supervised each significant step.
- Investigate and document any deviation within the batch record.
- Missing signatures, actual results, or in-process control entries.
- Records completed retrospectively rather than as each step is performed.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 4× the rate of the average FDA-cited firm (30.9% vs 7.8%), across 288 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Your batch production record did not include complete information relating to the production and control of each batch.
Your batch production record did not include complete information relating to the production and control of each batch.
Your batch production record did not include complete information relating to the production and control of each batch.
Your batch production record did not include complete information relating to the production and control of each batch.
Your batch production record did not include complete information relating to the production and control of each batch.
Your batch production record did not include complete information relating to the production and control of each batch.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →