Compliance and communications

Compliance & Communications

Public filings and regulatory disclosures.

FDA inspection reports, court filings, and state sterile-compounding inspection documents. Available for procurement, audit, and legal review.

U.S. Food and Drug Administration

FDA

FDA inspection filings.

FDA inspection reports (Form 483 and Establishment Inspection Reports), our formal responses, and litigation documents tied to FDA inspectional activity.

Plaintiff's Motion to Compel Production of Documents and for Leave to Conduct Limited DiscoveryCourt filingView FileHybrid 2021 FDA Form 483 ResponseFDA inspection responseView FilePlaintiff's Reply to Defendant's Opposition (Limited Discovery)Court filingView FileFDA Form 483 Establishment Inspection Report (Copy 2)FDA EIRView FileFDA Form 483 Establishment Inspection ReportFDA EIRView FileFDA Opposition to Motion to CompelCourt filingView File2023 FDA Form 483 Inspection Appeal PetitionFDA appealView File
Florida Department of Health

State

State sterile compounding inspection.

The most recent state sterile-compounding inspection acceptance letter for Hybrid Pharma's Deerfield Beach facility, confirming the Corrective Action Plan submitted in response to the February 2026 inspection.

Florida DOH — Sterile Compounding CAP Acceptance LetterApril 2026 · Florida Department of HealthView File
U.S. Drug Enforcement Administration

DEA

DEA-registered research.

Analytical work performed under DEA registration. Click any poster to open the full image in a new tab.

Development and Validation of Lyophilized Psilocybin for IV Administration

Full ISRP 2026 poster

Development and Validation of Lyophilized Psilocybin for IV Administration

In-Use Testing of Reconstituted Psilocybin in Syringe

HPLC stability in syringe

In-Use Testing of Reconstituted Psilocybin in Syringe

Impurity at RRT 1.9

Related-substance characterization

Impurity at RRT 1.9

Extended Stability Testing of Lyophilized Product

HPLC peak analysis at 5 / 25 / 40 °C

Extended Stability Testing of Lyophilized Product

News & updates

Latest from compliance.

Recent inspection outcomes, license renewals, and audit-pack updates.

News feed coming soon. Pull entries from the legacy site's/news/archive and they'll appear here.

Need documentation that isn't listed?

Procurement, audit, and legal review teams can request the full audit pack — cGMP procedures, environmental monitoring records, batch records, USP <797> certification, and sterility validation.

Request documentation