Scope & Applicability
Product Classes
3Human and Animal Food
Products requiring food facility registration under CPG Sec. 100.250.
Devices
Clinical investigations of medical devices
Drugs
Clinical investigations of drugs, including human drugs and biological products
Stakeholders
1Contract Sterilizers
Entity responsible for sterilization services; Entities performing sterilization services; Registration and regulatory requirements
Identified Hazards
Hazards
1Potential Hazards to the Public Health
Reporting responsibility defined in CPG Sec. 100.100.
Related Warning Letters (2)
- 2022-06-28
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
- 2020-05-05
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
See Also (8)
- Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (Status: Final)
- Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (Status: Final)
- Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act (Status: Draft)
- Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry (Status: Draft)
- Identifying Trading Partners Under the Drug Supply Chain Security Act (Status: Draft)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Using Electronic Means to Distribute Certain Product Information: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)