Regulatory System of Record

Defensible minimal-manipulation posture. On every HCT/P. Every time guidance changes.

BioIntel.io scores every tissue, cell, and biologics product against the 21 CFR 1271.10(a) four-prong test, retains a counsel-ready audit trail, and automatically re-scores your entire portfolio the moment FDA issues new guidance. Built for HCT/P manufacturers who cannot afford another warning letter.

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Total Actions Tracked

+0 last 30 days

Critical Severity

0 high severity

Most Active Agency

FDA

0 enforcement actions

Top Category

Unapproved Drug Claims

0 actions flagged

Enforcement Actions by Agency

FDA

180485.3%

DOJ

26512.5%

State AG

331.6%

FTC

100.5%

SEC

30.1%

Failure Category Breakdown

Unapproved Drug Claims712

GMP Deficiency695

Dietary Supplements124

Advertising & Promotion120

Compounding Pharmacy110

Other Violations93

Clinical Research (BIMO)66

Stem Cell / Exosome Products48

Biologics Compliance (CBER)43

Regenerative Medicine41

Medical Devices16

Weight Loss / GLP-113

Unapproved Biologic7

Peptide Therapy6

Health Claims5

Securities Fraud (Health / Biotech)3

Weight Loss Supplement2

GLP-1 Weight Loss Telehealth1

Tejocote Root (Yellow Oleander)1

Mood/Energy Supplement1

COVID-19 Treatment1

Stem Cell Therapy1

Memory/Cognitive Supplement1

Delta-8 THC Copycat Products1

Tianeptine Nootropic1

Alcohol-Craving Supplement1

Smoking-Cessation Supplement1

Various Supplement Categories1

What Happens After a Warning Letter

Recent enforcement actions. Every row is an official FDA, CBER, OPDP, FTC, DOJ, SEC or state attorney-general action, synced daily. Open the Heatmap for links to each letter.

Date	Agency	Type	Target	Category	Severity	Region
2026-10-06	FDA	Warning Letter	Eurofins SF Analytical Laboratories, Inc.	GMP Deficiency	high	US
2026-10-06	FDA	Warning Letter	Lovelace Biomedical Research Institute	Other Violations	high	US
2026-10-05	FDA	Warning Letter	Silgan Dispensing Systems	GMP Deficiency	high	US
2026-10-02	FDA	Warning Letter	Hanlim Pharm Co., Ltd.	GMP Deficiency	high	US
2026-10-01	FDA	Warning Letter	Graceful Touch, LLC	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	The Platinum Healthcare LLC	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	Walmart, Inc.	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	OrganiCare, LLC / OrganiCare Nature’s Science, LLC	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	Bioactive Services USA, LLC / Herstat Inc.	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	Terramed	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	Aidance Scientific, Inc.	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	Amazon.com, Inc.	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	DesBio/Deseret Biologicals, Inc.	Unapproved Drug Claims	high	US
2026-10-01	FDA	Warning Letter	RoyceDerm LLC	Unapproved Drug Claims	high	US
2026-09-30	SEC	Litigation Release	Mukesh Asudani	Securities Fraud (Health / Biotech)	high	US
2026-09-30	DOJ	Criminal Prosecution	Dauphin County Man Ordered To Forfeit $180,000 For Distributing Misbranded Drugs And Money Laundering	Unapproved Drug Claims	critical	US
2026-09-29	SEC	Litigation Release	Cheryl R. Kramer	Securities Fraud (Health / Biotech)	high	US
2026-09-28	FDA	Untitled Letter	Evolus, Inc.	Advertising & Promotion	medium	US
2026-09-24	FDA	Warning Letter	Cheap Medicine Shop/www.cheapmedicineshop.com	Unapproved Drug Claims	high	US
2026-09-23	FDA	Warning Letter	Online Generic Medicine/www.onlinegenericmedicine.com	Unapproved Drug Claims	high	US
2026-09-23	FDA	Warning Letter	Jiangmen Shuizirun Sanitary Articles Co., Ltd.	GMP Deficiency	high	US
2026-09-22	FDA	Warning Letter	Fresenius Kabi USA LLC	GMP Deficiency	high	US
2026-09-22	FDA	Warning Letter	Unilam Co., LTD	GMP Deficiency	high	US
2026-09-21	DOJ	Criminal Prosecution	Former Connecticut Resident Guilty of Operating Websites to Illegally Sell Misbranded and Unapproved Drugs	Unapproved Drug Claims	critical	US
2026-09-21	FDA	Warning Letter	Babikian Healthcare Products CJSC	GMP Deficiency	high	US
2026-09-18	FDA	Warning Letter	Empower Clinic Services, LLC dba Empower Pharmacy	GMP Deficiency	high	US
2026-09-18	State AG	State AG Action	Attorney General Brenna Bird Urges Federal Government to Crack Down on Dangerous Counterfeit Chinese GLP-1s	Weight Loss / GLP-1	high	Iowa
2026-09-18	State AG	State AG Action	Attorney General Marshall Leads Coalition Alerts National Security Council to Exploitation of FDA Approved Drugs by China Supply Chain	Unapproved Drug Claims	high
2026-09-18	FDA	Warning Letter	Curia New York, Inc.	GMP Deficiency	high	US
2026-09-17	FDA	Warning Letter	Bentley Laboratories LLC	GMP Deficiency	high	US
2026-09-16	SEC	Litigation Release	Jessica Richman and Zachary Apte	Securities Fraud (Health / Biotech)	high	US
2026-09-14	FDA	Warning Letter	Celmade	Unapproved Drug Claims	high	US
2026-09-14	FDA	Warning Letter	SCA Pharmaceuticals, LLC	GMP Deficiency	high	US
2026-09-11	FDA	Warning Letter	NexCell Scientific Inc	Unapproved Biologic	high	US
2026-09-08	FDA	Warning Letter	kdc/one Chatsworth, Inc.	GMP Deficiency	high	US
2026-09-04	FDA	Warning Letter	Bausch & Lomb Inc.	GMP Deficiency	high	US
2026-09-02	FDA	Warning Letter	TCI Co., Ltd BioCosme PABP BRANCH	GMP Deficiency	high	US
2026-09-01	FDA	Warning Letter	Happy Farm Botanicals, Inc.	GMP Deficiency	high	US
2026-09-01	FDA	Warning Letter	O.N. Diagnostics, LLC	Unapproved Drug Claims	high	US
2026-08-27	FDA	Warning Letter	Stephen J. Fallon, Ph.D.	Clinical Research (BIMO)	high	US
2026-08-27	FDA	Warning Letter	Jabil Inc.	GMP Deficiency	high	US
2026-08-25	FDA	Warning Letter	Fresenius Medical Care AG & Co. KGaA	GMP Deficiency	high	US
2026-08-25	FDA	Warning Letter	Advance-Esthetic LLC	GMP Deficiency	high	US
2026-08-24	FDA	Warning Letter	Peptide Partners LLC	Unapproved Drug Claims	high	US
2026-08-24	FDA	Warning Letter	Peak Performance Peptides	Unapproved Drug Claims	high	US
2026-08-24	FDA	Warning Letter	BioDrive, Inc.	Dietary Supplements	high	US
2026-08-24	FDA	Warning Letter	NuScience Peptides LLC	Unapproved Drug Claims	high	US
2026-08-24	FDA	Warning Letter	TXP Innovations LLC dba Tex Peptides	Unapproved Drug Claims	high	US
2026-08-24	FDA	Warning Letter	Royal Peptides LLC	Unapproved Drug Claims	high	US
2026-08-21	FDA	Untitled Letter	Alar Pharmaceuticals Inc.	Advertising & Promotion	medium	US
2026-08-21	FDA	Warning Letter	Lion Street Medical, d/b/a Pensar Medical LLC	Unapproved Drug Claims	high	US
2026-08-18	FDA	Warning Letter	Reliance Life Sciences Private Limited	GMP Deficiency	high	US
2026-08-18	FDA	Warning Letter	PReye, LLC	GMP Deficiency	high	US
2026-08-18	FDA	Warning Letter	Shoolin Pharma Chem LLP	GMP Deficiency	high	US
2026-08-14	FDA	Warning Letter	R3 Medical Companies	Unapproved Biologic	high	US
2026-08-13	FDA	Warning Letter	Eugia Pharma Specialities Limited	GMP Deficiency	high	US
2026-08-13	FDA	Warning Letter	Suretec Innovations, LLC	GMP Deficiency	high	US
2026-08-12	FDA	Warning Letter	Auriga Research Pvt. Ltd.	GMP Deficiency	high	US
2026-08-12	FDA	Warning Letter	K.C. Pharmaceuticals, Inc.	GMP Deficiency	high	US
2026-08-11	DOJ	Criminal Prosecution	Justice Department Files Complaint to Stop Washington Firm from Manufacturing and Selling Adulterated Food Products	Unapproved Drug Claims	critical	US
2026-08-07	FDA	Warning Letter	Pine Pharmaceuticals, LLC	Compounding Pharmacy	high	US
2026-08-07	FDA	Warning Letter	Safrel Pharmaceuticals LLC	GMP Deficiency	high	US
2026-08-06	DOJ	Criminal Prosecution	Justice Department Files Complaint to Stop Nevada Firm from Manufacturing and Selling Adulterated and Misbranded Dental Products	Unapproved Drug Claims	critical	US
2026-08-06	FDA	Warning Letter	Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.	GMP Deficiency	high	US
2026-07-31	FDA	Warning Letter	FairyGene, Inc.	GMP Deficiency	high	US
2026-07-30	FDA	Warning Letter	Lico Industries, LLC., d.b.a. American Towelette Company	GMP Deficiency	high	US
2026-07-30	DOJ	Criminal Prosecution	Illinois Man and Indiana Woman Sentenced Respectively to 70 Months and 16 Months in Prison For Selling Unapproved Drugs in Interstate Commerce	Unapproved Drug Claims	critical	US
2026-07-29	FTC	FTC Action	FTC and States Act Against Hims & Hers for Deceptive and Unlawful Privacy Practices	Advertising & Promotion	high	US
2026-07-28	FDA	Untitled Letter	Travere Therapeutics, Inc.	Advertising & Promotion	medium	US
2026-07-27	FDA	Warning Letter	Maria E. De La Torre Silva, M.D.	Clinical Research (BIMO)	high	US
2026-07-27	FDA	Warning Letter	Woodbine Products Company Inc.	GMP Deficiency	high	US
2026-07-24	FDA	Warning Letter	Dabur India Limited	GMP Deficiency	high	US
2026-07-24	FDA	Warning Letter	Thomas Brunner Hygiene GmbH	GMP Deficiency	high	US
2026-07-24	FDA	Warning Letter	Nipro Renal Solutions USA, Corporation	GMP Deficiency	high	US
2026-07-21	FDA	Warning Letter	Koven Technologies, Inc.	GMP Deficiency	high	US
2026-07-17	DOJ	Criminal Prosecution	Nevada Man Pleads Guilty to Smuggling and Selling Misbranded Erectile Dysfunction and Prescription Drugs	Unapproved Drug Claims	critical	US
2026-07-16	FDA	Warning Letter	Island Kinetics, Inc. d.b.a. CoValence Laboratories	GMP Deficiency	high	US
2026-07-15	FTC	FTC Action	FTC Approves Final Order Against TruHeight for Deceptive and Unsubstantiated Advertising of Supplements for Kids and Teens	Dietary Supplements	high	US
2026-07-15	FDA	Untitled Letter	Sanofi Vaccines US Inc.	Advertising & Promotion	medium	US
2026-07-13	FDA	Warning Letter	Almon Healthcare Private Limited	GMP Deficiency	high	US
2026-07-13	FDA	Warning Letter	Shimoga Chemicals	GMP Deficiency	high	US
2026-07-13	FDA	Untitled Letter	Viatris Specialty LLC	Advertising & Promotion	medium	US
2026-07-13	FDA	Warning Letter	BioMylz Pvt. Ltd.	GMP Deficiency	high	US
2026-07-10	FDA	Warning Letter	Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.	Other Violations	high	US
2026-07-08	FDA	Warning Letter	Spa De Soleil, Inc.	GMP Deficiency	high	US
2026-07-07	FDA	Warning Letter	Specialty Health Products CO, LLC	GMP Deficiency	high	US
2026-07-07	FDA	Untitled Letter	Fenwal International, Inc.	Biologics Compliance (CBER)	medium	US
2026-07-02	FDA	Warning Letter	International Medication Systems Limited	GMP Deficiency	high	US
2026-07-01	DOJ	Criminal Prosecution	Massachusetts Couple Sentenced to Prison for Importing Misbranded Drugs From China and Selling Them to Customers in U.S. for Performance Enhancing Purposes	Unapproved Drug Claims	critical	US
2026-06-25	FDA	Warning Letter	Excelvision - Fareva	GMP Deficiency	high	US
2026-06-24	FDA	Warning Letter	Wizcure Pharmaa Private Limited	GMP Deficiency	high	US
2026-06-24	FDA	Untitled Letter	Lundbeck Seattle Biopharmaceuticals, Inc.	Advertising & Promotion	medium	US
2026-06-23	FDA	Warning Letter	Buy Keta Online / www.buyketaonline.com	Unapproved Drug Claims	high	US
2026-06-23	FDA	Warning Letter	Ketamine Troche Store / www.ketaminetrochestore.com	Unapproved Drug Claims	high	US
2026-06-23	FDA	Warning Letter	All Ketamine HCL / www.allketaminehcl.com	Unapproved Drug Claims	high	US
2026-06-23	FDA	Warning Letter	Ketacyn Pharmaceuticals / www.ketacynpharma.com	Unapproved Drug Claims	high	US
2026-06-23	FDA	Warning Letter	Ketdaxandrugs / www.ketdaxandrugs.org	Unapproved Drug Claims	high	US
2026-06-23	FDA	Warning Letter	ketaminetroches.com	Unapproved Drug Claims	high	US
2026-06-23	FDA	Warning Letter	Extra Medication / www.extramedication.com	Unapproved Drug Claims	high	US
2026-06-23	FDA	Warning Letter	LyfeUnit / www.lyfeunit.com	Unapproved Drug Claims	high	US

Built for HCT/P Manufacturers and CGT Sponsors

The platform is bought by the people who own defensibility when a 483 lands.

Regulatory Affairs

Score every product against 21 CFR 1271.10(a). Retain CFR citations. Re-run the portfolio the moment guidance changes.

General Counsel

Counsel-ready defensibility memos. Cryptographically signed audit trail. Counsel Co-Sign workflow for outside-counsel attestation.

Compliance Officers

Enforcement Risk Score on every claim before it ships. State AG, FTC, and OPDP signals surfaced in one feed.

Why This Is Not Replaced by Outside Counsel

Counsel gives advice. BioIntel creates the record.

Outside counsel

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Opinion memos sit in email
Rarely re-run when guidance updates
No structured audit trail

BioIntel

Continuous, cryptographically signed audit trail
Automatic re-score when FDA guidance changes
Structured defensibility on every product and claim
Counsel Co-Sign workflow places your outside firm on record

How BioIntel Prevents the Next Warning Letter

Every claim, every product, every time guidance changes — scored against the 21 CFR 1271 four-prong test with a cryptographically signed audit trail your counsel co-signs.

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