FDA 483 OBSERVATION · #764 OF 1,000 MOST-CITED
Identification of containers, lines, equipment
FDA cited this observation 21 times across 20 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
All compounding and storage containers, processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents and the phase of processing of the batch.
All compounding and storage containers used during the production of a batch of drug product is not properly identified at all times to indicate contents and the phase of processing of the batch.
All major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents.
All compounding and storage containers, processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate contents and the phase of processing of the batch.
All processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate the phase of processing of the batch.
All major equipment used during the production of a batch of drug product is not properly identified at all times to indicate the phase of processing of the batch.
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.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.