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.

Claim Your Free Regulatory Exposure Audit See the 21 CFR 1271 Classifier

One complimentary audit per company · No subscription required · ~15 minutes

Total Actions Tracked

+0 last 30 days

Critical Severity

0 high severity

Most Active Agency

FDA

0 enforcement actions

Top Category

Regenerative Medicine

0 actions flagged

Where Companies Fail the Four-Prong Test (by agency)

FDA

3660.0%

FTC

2440.0%

Failure Category Breakdown

Regenerative Medicine8

Dietary Supplements6

Peptide Therapy4

Longevity & Anti-Aging4

Biologics4

Unapproved Drug Claims2

Weight Loss Supplement2

Genetic Testing2

Unapproved Drug Import1

GLP-1 Weight Loss Telehealth1

Safety Concern1

Tejocote Root (Yellow Oleander)1

Misbranded Biologic1

GLP-1 Drug Marketing1

Deceptive Advertising1

Joint Health Supplement1

Weight Loss Gummies1

GMP Deficiency1

Mineral Supplements1

Intravenous CBD1

Mood/Energy Supplement1

COVID-19 Treatment1

Stem Cell Therapy1

Exosome/Stem Cell Products1

Memory/Cognitive Supplement1

Glutathione Supplement1

Delta-8 THC Copycat Products1

Unapproved Biologic1

Probiotic Supplement1

Sexual Enhancement Supplements1

Probiotics1

IV Therapy1

Tianeptine Nootropic1

Alcohol-Craving Supplement1

Smoking-Cessation Supplement1

Various Supplement Categories1

What Happens After a Warning Letter

Recent enforcement actions. Each one maps to a four-prong failure BioIntel flags before the 483 lands.

Date	Agency	Type	Target	Category	Severity	Region
2026-02-10	FDA	Warning Letter	RegenMed Labs	Unapproved Drug Claims	high	US
2026-01-05	FDA	Import Alert	Multiple (Peptide Suppliers)	Unapproved Drug Import	high	US
2025-12-03	FTC	Consent Decree	NextMed / Southern Health Solutions	GLP-1 Weight Loss Telehealth	critical	US
2025-12-01	FDA	injunction	ExoPharm	Safety Concern	critical	US
2025-11-15	FDA	Warning Letter	Kimera Labs	Unapproved Drug Claims	high	US
2025-11-15	FDA	Warning Letter	Multiple Manufacturers	Tejocote Root (Yellow Oleander)	high	US
2025-09-22	FDA	Warning Letter	Organicell Regenerative Medicine	Misbranded Biologic	high	US
2025-09-09	FDA	Warning Letter	Eli Lilly and Company	GLP-1 Drug Marketing	high	US
2025-08-10	FTC	FTC Action	Elevai Labs	Deceptive Advertising	high	US
2025-07-17	FDA	Warning Letter	Valentine Enterprises Inc.	Joint Health Supplement	high	US
2025-07-17	FDA	Warning Letter	Vidaslim Co.	Weight Loss Gummies	high	US
2025-07-15	FTC	FTC Action	Roca Labs Inc.	Weight Loss Supplement	high	US
2025-06-18	FDA	Warning Letter	Direct Biologics	GMP Deficiency	high	US
2025-04-02	FDA	Warning Letter	NeuroVive Labs	Peptide Therapy	high	US
2025-03-28	FDA	Warning Letter	Mother Earth Minerals Inc.	Mineral Supplements	high	US
2025-03-20	FTC	FTC Action	ClearPath Biologics	Regenerative Medicine	high	US
2025-03-15	FDA	Warning Letter	PureLife Biologics	Regenerative Medicine	high	US
2025-03-06	FDA	Warning Letter	Pico IV Inc.	Intravenous CBD	high	US
2025-02-28	FTC	FTC Action	VitalMax Supplements	Dietary Supplements	high	US
2025-02-26	FDA	Warning Letter	bio LIT manufacturer	Mood/Energy Supplement	high	US
2025-02-10	FDA	Warning Letter	TelePeptide Health	Peptide Therapy	high	US
2025-01-22	FDA	Warning Letter	NeuroPeptide Labs	Peptide Therapy	high	US
2025-01-15	FTC	FTC Action	MetaBoost Labs	Dietary Supplements	high	US
2025-01-15	FTC	FTC Action	Golden Sunrise Nutraceutical Inc.	COVID-19 Treatment	high	US
2025-01-08	FTC	injunction	Stem Cell Institute of America LLC	Stem Cell Therapy	critical	US
2024-12-30	FDA	Warning Letter	Evolutionary Biologics Inc.	Exosome/Stem Cell Products	high	US
2024-12-06	FTC	injunction	Quincy Bioscience (Prevagen)	Memory/Cognitive Supplement	critical	US
2024-12-05	FDA	Warning Letter	CryoStem International	Regenerative Medicine	high	US
2024-11-14	FTC	FTC Action	GreenLeaf Health Co	Dietary Supplements	high	US
2024-11-13	FDA	Warning Letter	Western Innovations Inc.	Glutathione Supplement	high	US
2024-10-03	FDA	Warning Letter	ExoCell Therapeutics	Regenerative Medicine	high	US
2024-10-02	FDA	Warning Letter	Body Shape Weight Loss System	Weight Loss Supplement	high	US
2024-09-15	FDA	Warning Letter	StemVita Clinics	Regenerative Medicine	high	US
2024-08-19	FTC	FTC Action	ImmunoBoost Inc	Dietary Supplements	high	US
2024-07-15	FDA	Warning Letter	Multiple Delta-8 THC Companies	Delta-8 THC Copycat Products	high	US
2024-07-11	FDA	Warning Letter	BioAge Longevity	Longevity & Anti-Aging	high	US
2024-06-05	FTC	FTC Action	TruNature Biologics	Biologics	high	US
2024-05-22	FTC	FTC Action	GenomeWell Inc	Genetic Testing	high	US
2024-04-22	FDA	seizure	Pacific Stem Cell Center	Regenerative Medicine	critical	US
2024-03-15	FDA	Consent Decree	US Stem Cell Inc	Unapproved Biologic	critical	US
2024-03-08	FTC	FTC Action	GeneTech Wellness	Genetic Testing	high	US
2024-02-14	FTC	FTC Action	AgeBlock Therapeutics	Longevity & Anti-Aging	high	US
2024-02-04	FDA	Warning Letter	IsoThrive Inc.	Probiotic Supplement	high	US
2024-01-30	FDA	Warning Letter	MitoCell Research	Longevity & Anti-Aging	high	US
2024-01-24	FDA	Warning Letter	Amazon.com Inc.	Sexual Enhancement Supplements	high	US
2023-12-11	FTC	FTC Action	ProBio Therapeutics	Probiotics	high	US
2023-11-30	FTC	FTC Action	EliteIV Wellness	IV Therapy	high	US
2023-11-23	FDA	Warning Letter	Multiple Companies (Neptunes Fix)	Tianeptine Nootropic	high	US
2023-11-05	FDA	Warning Letter	Advanced Peptide Sciences	Peptide Therapy	high	US
2023-10-17	FTC	FTC Action	NovaSkin Biologics	Biologics	high	US
2023-09-22	FDA	injunction	RegenX Medical	Regenerative Medicine	critical	US
2023-08-28	FDA	Warning Letter	BioMatrix Therapeutics	Biologics	high	US
2023-08-14	FTC	FTC Action	OmegaHealth Labs	Dietary Supplements	high	US
2023-07-18	FTC	FTC Action	Rejuvica LLC / Sobrenix	Alcohol-Craving Supplement	high	US
2023-07-03	FDA	Warning Letter	CellVita Therapeutics	Regenerative Medicine	high	US
2023-06-30	FTC	Consent Decree	Smoke Away / Michael J. Connors	Smoking-Cessation Supplement	critical	US
2023-06-19	FTC	FTC Action	BioDefense Nutrition	Dietary Supplements	high	US
2023-05-08	FDA	Warning Letter	LongevityRx Inc	Longevity & Anti-Aging	high	US
2023-04-13	FTC	FTC Action	670 Health Product Companies	Various Supplement Categories	high	US
2023-04-11	FTC	FTC Action	PrimeBio Health	Biologics	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

Bills hours, not retention
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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