FDA 483 OBSERVATION · #100 OF 1,923 MOST-CITED
Master manufacturing record - each batch
FDA cited this observation 295 times across 266 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.
Master production and control records were inadequate or not followed — the approved master defining how each batch of a product is made was missing required content, or batch records were not prepared as an accurate reproduction of it.
Why FDA writes it — The master record is the controlled definition of how every batch must be made. If it is incomplete, or batch records do not accurately reproduce it, batches are made without a reliable, consistent instruction — the root of variability and error.
- Prepare master production and control records for each product and batch size, independently checked, dated, and signed by qualified individuals.
- Include the product name/strength, the components and amounts, a complete manufacturing and control description, specifications, and sampling and testing procedures.
- Ensure each batch record is an accurate reproduction of the appropriate master record.
- Control changes to the master through change control.
- Master records missing required content or not independently verified.
- Batch records that diverge from an uncontrolled or outdated master.
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 3.7× the rate of the average FDA-cited firm (28.6% vs 7.8%), across 266 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 and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
You did not prepare and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
You did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
You did not prepare and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
You did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
You did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
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 →