FDA 483 OBSERVATION · #51 OF 1,923 MOST-CITED
Computer control of master formula records
FDA cited this observation 490 times across 431 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.
Automatic, mechanical, or electronic equipment (including computers) used in manufacturing or control was not adequately controlled — including inadequate controls over master formula and production records held or processed electronically, and over changes to them.
Why FDA writes it — When master formula and production records are computer-controlled, the integrity of those records depends on system controls — access, change control, and backups. Weak controls let the records that define how a product is made be altered without detection, a direct data-integrity and product-quality risk.
- Validate computer or related systems used in manufacturing and control to ensure they perform as intended.
- Control access and changes to master formula and production records held electronically, with appropriate authority checks.
- Maintain backup data and protect records against loss, alteration, or unauthorized change.
- Keep audit trails for changes to critical electronic records and review them.
- Electronic master/production records without adequate access control or change control.
- No validated backup and recovery, so record integrity cannot be assured over time.
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 3.6× the rate of the average FDA-cited firm (27.6% vs 7.8%), across 431 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
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
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 →