This is a small point, but it took me longer than expected to locate, so I’m posting it in case it saves someone else time.
When FDA refuses an entry line, the refusal record may provide numeric charge codes with little explanation—for example, “324, 482”. On their own, those numbers are not especially helpful.
FDA publishes a reference table called ACT_SECTION_CHARGES, which maps each code to a short charge name and the relevant section of the Federal Food, Drug, and Cosmetic Act.
Charge reference table:
https://datadashboar...ION_CHARGES.CSV
Import refusal records:
https://datadashboar...imprefusals.htm
Once the records are joined to the reference table:
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324 is NO ENGLISH, under section 403(f), misbranding.
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482 is NUTRIT LBL, under section 403(q), misbranding.
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83 is NO PROCESS, under section 402(a)(4), adulteration.
Two things initially seemed counterintuitive to me.
First, some charges that may arise from filing or documentation failures are classified as adulteration rather than misbranding. NO PROCESS and NEEDS FCE, for example, relate to requirements affecting low-acid canned and acidified foods. A product may therefore receive an adulteration charge even where the refusal record does not identify a physical defect in the product itself.
Second, one refused entry line can carry several charges. Counting refused lines and counting charge instances will therefore produce different results. It is worth defining which measure is being used before quoting a total or percentage.
FDA also provides programmatic access through its Data Dashboard API. Credentials are obtained through the OII Unified Logon system, and requests require Authorization-User and Authorization-Key headers.
Kind regards,
Emily
