FDA 483 OBSERVATION · #60 OF 1,923 MOST-CITED
Supplier approval - document
FDA cited this observation 427 times across 401 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 receiving facility did not adequately document its approval of suppliers under its supply-chain program, so it could not demonstrate that raw materials whose hazards are controlled upstream came from approved suppliers.
Why FDA writes it — When a hazard is controlled by a supplier rather than the receiving facility, documented supplier approval is what proves the control is real. Missing approval documentation means the facility cannot show its upstream hazard control is anything more than an assumption.
- Approve suppliers for raw materials and ingredients whose hazards require a supply-chain-applied control, and document the approval.
- Use temporary receipt from unapproved suppliers only with adequate verification, documented.
- Keep records identifying approved suppliers and the basis for approval.
- Update approvals when supplier performance or the hazard changes.
- Supplier approval done informally without records to demonstrate it.
- Receiving from unapproved suppliers without the documented interim verification the rule allows.
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 1.5× the rate of the average FDA-cited firm (12.0% vs 7.8%), across 401 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 document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.
You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.
You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.
You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.
You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.
You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.
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 →