Every case in this library is a real, public FDA, EMA, or MHRA enforcement record — cross-referenced against the agency’s own database, dated, and updated as our weekly regulatory intelligence pipeline identifies new actions. Nothing here is anonymized or hypothetical.
How this library is built
Each entry is sourced directly from a named, public regulatory action — a Warning Letter, FDA Form 483, Import Alert, Recall, Consent Decree, or international enforcement record from EMA or MHRA. Cases are cross-referenced against related actions for the same company (a Warning Letter checked against related import alerts or recalls) as part of XGene’s ongoing weekly/monthly/quarterly intelligence pipeline. We do not fabricate or generalize cases; every name is drawn from the public record.
The 6 enforcement categories
An overview of every enforcement type tracked in this library, and how many named cases sit under each.
Warning Letter — 19 cases in this library
A formal FDA notice issued when an inspection or investigation finds significant violations of FDA regulations, requiring prompt corrective action.
FDA Form 483 — 4 cases in this library
A list of inspectional observations issued at the conclusion of an FDA inspection under FD&C Act Section 704(b), documenting conditions that may violate the FD&C Act.
Import Alert — 1 case in this library
An FDA mechanism authorizing detention without physical examination of shipments from a firm or country with a documented pattern of violations.
Recall — 8 cases in this library
Voluntary or FDA-requested removal of a distributed product from the market due to a defect or safety concern, classified by risk severity (Class I/II/III).
Consent Decree — 1 case in this library
A court-approved settlement between FDA and a company, typically following a Warning Letter, imposing binding remediation requirements and independent oversight.
International Enforcement — 3 cases in this library
Enforcement actions issued by non-US authorities (EMA, MHRA, and others) against manufacturers, often in coordination with or parallel to FDA action.
The full case library — 36 named enforcement actions
Warning Letter (19 cases)
Alchymars
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Almon Healthcare
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
BioMylz
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Excelvision (Fareva)
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Gopaldas Visram & Co.
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Huons Co.
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
International Medication Systems
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Island Kinetics (CoValence Laboratories)
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Jubilant HollisterStier
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Laboratorios Dr. Collado
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Macau-Union Pharmaceutical
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
PLZ Corp
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Pharmathen International
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Revlon Group Holdings
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Sante Manufacturing
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Shimoga Chemicals
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Spa De Soleil
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Umendra Life Sciences
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
Wizcure Pharma
Public FDA/EMA/MHRA enforcement record — tagged under Warning Letter in the XGene regulatory intelligence taxonomy.
FDA Form 483 (4 cases)
BPI Labs LLC
Public FDA/EMA/MHRA enforcement record — tagged under FDA Form 483 in the XGene regulatory intelligence taxonomy.
Catalent Indiana LLC
Public FDA/EMA/MHRA enforcement record — tagged under FDA Form 483 in the XGene regulatory intelligence taxonomy.
QuVa Pharma Inc.
Public FDA/EMA/MHRA enforcement record — tagged under FDA Form 483 in the XGene regulatory intelligence taxonomy.
Wells Pharma of Houston LLC
Public FDA/EMA/MHRA enforcement record — tagged under FDA Form 483 in the XGene regulatory intelligence taxonomy.
Import Alert (1 case)
Babikian Healthcare Products
Public FDA/EMA/MHRA enforcement record — tagged under Import Alert in the XGene regulatory intelligence taxonomy.
Recall (8 cases)
Amgen Inc.
Public FDA/EMA/MHRA enforcement record — tagged under Recall in the XGene regulatory intelligence taxonomy.
Asclemed USA
Public FDA/EMA/MHRA enforcement record — tagged under Recall in the XGene regulatory intelligence taxonomy.
Blaine Labs
Public FDA/EMA/MHRA enforcement record — tagged under Recall in the XGene regulatory intelligence taxonomy.
CareFusion 213 (BD)
Public FDA/EMA/MHRA enforcement record — tagged under Recall in the XGene regulatory intelligence taxonomy.
Cipla USA
Public FDA/EMA/MHRA enforcement record — tagged under Recall in the XGene regulatory intelligence taxonomy.
Gasco Industrial Corp.
Public FDA/EMA/MHRA enforcement record — tagged under Recall in the XGene regulatory intelligence taxonomy.
Lupin Pharmaceuticals
Public FDA/EMA/MHRA enforcement record — tagged under Recall in the XGene regulatory intelligence taxonomy.
Reliance Life Sciences
Public FDA/EMA/MHRA enforcement record — tagged under Recall in the XGene regulatory intelligence taxonomy.
Consent Decree (1 case)
PharMEDium Services
Public FDA/EMA/MHRA enforcement record — tagged under Consent Decree in the XGene regulatory intelligence taxonomy.
International Enforcement (3 cases)
Bio-Thera Solutions (EMA)
Public FDA/EMA/MHRA enforcement record — tagged under International Enforcement in the XGene regulatory intelligence taxonomy.
Geno Pharmaceuticals (MHRA)
Public FDA/EMA/MHRA enforcement record — tagged under International Enforcement in the XGene regulatory intelligence taxonomy.
Zenzi Pharmaceutical Industries (FDA + EMA)
Public FDA/EMA/MHRA enforcement record — tagged under International Enforcement in the XGene regulatory intelligence taxonomy.
Facing a similar enforcement action?
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