FDA 483 OBSERVATION · #135 OF 1,923 MOST-CITED
Reserve sample - collect, hold
FDA cited this observation 221 times across 209 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 firm failed to collect and retain reserve samples of active ingredients and/or each lot of finished drug product, in the required quantity, storage conditions, and retention period, as specified by §211.170 — including the twice-the-quantity-for-full-testing rule and the retention timeframe tied to expiry.
Why FDA writes it — Reserve samples are the firm’s only way to re-examine a released lot later — for a complaint, recall, stability signal, or field failure. FDA protects against a firm that cannot investigate its own distributed product because no representative retained sample of that lot exists.
- Retain reserve samples of each active ingredient lot and each finished-product lot in at least twice the quantity needed for full specification testing.
- Store reserves under the same conditions in which the marketed product is stored, in the marketed container-closure where required.
- Hold reserves for the required period beyond expiry (per §211.170) and control access and reconciliation.
- Log every reserve sample against its batch record so retention gaps are visible at release.
- Reserve quantities are set once and never rechecked against the current full-testing requirement.
- Active-ingredient reserves are overlooked because attention focuses only on finished product.
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 (29.7% vs 7.8%), across 209 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 collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.
You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.
You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.
You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.
You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.
You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.
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 →