What regulatory actions or warning letters has the FDA issued regarding Neurocept or its products?

1. What the record you gave actually contains: no Neurocept hits

The search results you supplied include many FDA-related pages — novel-drug approvals, newsroom items, and industry summaries — plus an article noting the FDA posted a slate of seven warning letters in mid‑2025 ^{[1] [3] [2]}. None of those snippets or titles, however, identify Neurocept or any Neurocept-branded product as the target of an FDA letter or regulatory action in the available clipset (not found in current reporting) ^[2].

2. The FDA’s public warning-letter process (context for what “would” appear)

When the FDA issues formal enforcement correspondence such as Warning Letters, it posts them on its Warning Letters page and industry press often aggregates them; the PharmTech piece in your results refers to a June 10, 2025 update in which the FDA posted several warning letters covering a range of violations ^[2]. If Neurocept had received a Warning Letter in that batch, it would normally appear on the FDA’s Warning Letters list and be noted in coverage such as PharmTech’s roundup ^[2].

3. What the roundups and newsletters in your set emphasize (why Neurocept might be missed)

The provided items largely cover FDA approvals, advisory actions and a few high‑profile safety policy moves — for example, novel‑drug approvals pages and regional FDA action updates in neurology — and an analysis piece listing a set of seven warning letters that addressed improper promotional claims and inspection findings ^{[1] [4] [2] [5]}. Those summaries focus on the companies cited in those postings; because Neurocept is not referenced in the snippets you shared, it may simply not be part of those updates (not found in current reporting) ^[2].

4. Two plausible explanations for the absence of Neurocept in these sources

First, Neurocept may not have been the subject of an FDA Warning Letter or high‑profile regulatory action during the periods covered by these search results, which emphasize 2024–2025 FDA activity ^{[1] [4]}. Second, Neurocept could have received lower‑profile correspondence (e.g., Form FDA 483 inspection observations, untitled letters, or communications not posted as public warning letters) that these specific summaries and press roundups did not capture — the provided materials do not enumerate every type of enforcement communication (available sources do not mention lower‑profile communications) ^[2].

5. How to verify whether Neurocept has any FDA correspondence (actionable next steps)

To confirm definitively, one should (a) search the FDA’s Warning Letters database and Warning Letters archive directly for the company name, (b) check the FDA’s Enforcement Reports and Inspectional Observations (Form 483) postings, and (c) review company press releases and SEC filings (if a public company) for references to FDA letters. The summaries you supplied show that industry outlets pick up the FDA’s posted warning letters ^[2], so a direct query of the FDA site is the fastest way to settle this ^[2].

6. Caveats and transparency about source limits

I must rely only on the documents you provided. These results include FDA pages, industry updates and media reporting about a set of warning letters, but none explicitly name Neurocept or its products; therefore I cannot assert that Neurocept received no FDA action beyond saying the available sources do not mention it (not found in current reporting) ^{[2] [1]}. If you want, provide additional links or allow me to search the live FDA databases so I can confirm whether any formal FDA Warning Letter or other regulatory action addressed Neurocept.