FDA 483 OBSERVATION · #149 OF 1,923 MOST-CITED
Batch record - every batch
FDA cited this observation 206 times across 184 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 prepared for each batch, or existing records are incomplete — missing the documentation of each significant step, in-process controls, equipment identification, and the accurate reproduction of the master production record required by §211.188.
Why FDA writes it — The batch record is the contemporaneous proof that a specific lot was made correctly. Without a complete record for every batch, FDA cannot confirm the product was manufactured per the approved process, and any deviation, weighing, or control that went unrecorded is unverifiable after the fact.
- Prepare a batch production and control record for every batch by accurately reproducing the approved master production record.
- Document each significant manufacturing step contemporaneously, including in-process control results and equipment/line identification.
- Capture actual quantities, yields, and the identity of personnel performing and checking each critical step.
- Require quality-unit review of the completed batch record as a release gate, with all discrepancies resolved.
- Steps are back-filled at end of shift rather than recorded at the time of performance, leaving gaps.
- The executed record diverges from the master because a process change was not carried into the batch template.
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 3.9× the rate of the average FDA-cited firm (29.9% vs 7.8%), across 184 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
You did not prepare a batch production record every time you manufactured a batch of dietary supplement.
You did not prepare a batch production record every time you manufactured a batch of dietary supplement.
You did not prepare a batch production record every time you manufactured a batch of dietary supplement.
You did not prepare a batch production record every time you manufactured a batch of dietary supplement.
You did not prepare a batch production record every time you manufactured a batch of dietary supplement.
You did not prepare a batch production record every time you manufactured a batch of dietary supplement.
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 →