FDA 483 OBSERVATION · #132 OF 1,923 MOST-CITED
Specifications - labels, packaging
FDA cited this observation 228 times across 196 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.
Written procedures and specifications for the receipt, identification, examination, storage, handling, and approval or rejection of labeling and packaging materials are lacking or inadequate, as required by §211.122 — the controls that keep incorrect or unapproved labels and packaging out of finished drug product.
Why FDA writes it — Labeling and packaging errors are a leading cause of drug recalls and patient harm — a mislabeled product can deliver the wrong drug or strength. FDA protects against unexamined or uncontrolled labeling by requiring specifications and approval controls before any label reaches the line.
- Establish specifications and written procedures for receipt, examination, and approval or rejection of all labeling and packaging materials.
- Examine incoming labeling against the approved specimen and quarantine until the quality unit approves it.
- Control storage and issuance so obsolete or superseded labeling is destroyed and cannot be reissued.
- Reconcile issued, used, and returned labeling for each batch to detect mix-ups or shortages.
- Labeling is received and used without a documented examination against an approved master specimen.
- Obsolete labels are not destroyed on a revision, so an outdated version is later pulled and applied.
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 3.8× the rate of the average FDA-cited firm (29.1% vs 7.8%), across 196 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 packaging specifications.
You did not establish label and packaging specifications.
You did not establish label and packaging specifications.
You did not establish packaging specifications.
You did not establish label and packaging specifications.
You did not establish label and packaging specifications.
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 →