FDA 483 OBSERVATION · #850 OF 1,000 MOST-CITED
Distinctive ID or code not recorded in batch record
FDA cited this observation 17 times across 17 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.
How FDA worded it — real examples
The batch records do not record the distinctive identification number to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
The batch records do not record the distinctive identification number to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
The batch records do not record the distinctive name of equipment to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
The batch records do not record the distinctive identification number to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
The batch records do not record the distinctive code to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
The batch records do not record the distinctive identification number and name of equipment to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
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. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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