Search
Search for firms, violations, and import refusal records
Search for firms, violations, and import refusal records
| Code | Charge Code | Description | Legal Section |
|---|---|---|---|
| 3847 | FDF4APIGMP | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is: | 501(a)(2)(B), 801(a)(3); ADULTERATION |
| 3761 | FILTH | The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance | 501(a)(1)Adulteration |