Import Alert 55-04

DETENTION WITHOUT PHYSICAL EXAMINATION OF PHARMACEUTICAL-USE GELATIN
FOR POTENTIALLY HAZARDOUS MICROBIOLOGICAL CONTAMINATION

FDA collected and analyzed samples of pharmaceutical use gelatin considered at risk for potentially hazardous microbial contamination and found them to be contaminated with spore forming bacteria. Spore forming bacteria are resistant to the types of production methods use to encapsulate dietary supplements and drug products and pose a health risk to immuno-compromised individuals.

Districts may detain, without physical examination, the specified products from the firms listed in the Red List of this Import Alert.

Districts should recommend detention without physical examination under this import alert when analytical results reveal the presence of potentially hazardous microbial contamination in gelatin intended for pharmaceutical use. Forward background information, including analytical worksheets and product labeling, to the Division of Import Operations (DIO). DIO will coordinate with CDER for concurrence.

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE).

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

For questions or issues involving import operations, contact the Division of Import Operations at (301) 796-0356.

For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at (301) 796-5992.

Pharmaceutical Gelatin

PROBLEM: Adulteration

Depending on the circumstances, the following charges are appropriate:

The article is subject to refusal of admission pursuant to section 801(a)(3) of the FFD&CA 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. [Adulteration, Section 501(a)(1)].
OASIS CHARGE CODE: 501a FILTH

AND/OR

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions
OASIS CHARGE CODE: MFR INSAN

AND/OR

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health [Adulteration, Section 501(a)(2)(A)].
OASIS CHARGE CODE: INSANITARY

AND/OR

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding of the article do not appear to conform to or are not operated or administered in conformity with current good manufacturing practices. [Adulteration, Section 501(a)(2)(B)].
OASIS CHARGE CODE: DRUG GMPs