FDA 483 OBSERVATION · #212 OF 1,923 MOST-CITED
Batch production and Batch Control Record Requirements
FDA cited this observation 140 times across 132 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 is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 5.5× the rate of the average FDA-cited firm (42.4% vs 7.8%), across 132 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
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding.
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing, packing and holding.
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding.
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 →