FDA 483 OBSERVATION · #92 OF 1,923 MOST-CITED
Written procedures - holding
FDA cited this observation 307 times across 283 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.
The manufacturer lacked adequate written procedures for the warehousing (holding) of drug products, so storage did not assure that quarantine, storage conditions, and distribution controls protected product quality.
Why FDA writes it — Product can be made correctly and then compromised in storage. Warehousing procedures control quarantine status, storage conditions, and orderly distribution; without them, unreleased product can be shipped, conditions can drift, and stock rotation can fail.
- Establish written procedures for warehousing that include quarantine of drug products before release.
- Store drug products under appropriate conditions of temperature, humidity, and light so that quality is not affected.
- Control distribution so that the oldest approved stock is distributed first, where appropriate.
- Maintain the status (quarantine/released/rejected) of stored product clearly.
- No control over release status in the warehouse, so unreleased product can ship.
- Storage conditions not controlled or monitored where product quality depends on them.
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 3.3× the rate of the average FDA-cited firm (25.8% vs 7.8%), across 283 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 establish procedures for holding and distributing operations.
You did not establish procedures for holding and distributing operations.
You did not establish and follow written procedures for holding and distributing operations.
You did not establish procedures for holding and distributing operations.
You did not establish procedures for holding and distributing operations.
You did not establish procedures for holding and distributing operations.
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 →