U.S. FDA’s Detention without Physical Examination (DWPE)
The U.S. Food and Drug Administration (FDA) office that handles petitions for removal from Import Alert held a conference call with members of the National Fisheries Institute (NFI) concerning procedures for removal from Import Alert 16-120 (Detention without physical examination of fish/fishery products from foreign processors/manufacturers not in compliance with seafood HACCP). Members of Registrar Corp’s Food Safety Department and Registrar Corp’s Label/Product Review Department participated in the teleconference.
During the teleconference, FDA official addressed: reasons that cause a firm to get on the Import Alert; documentation needed for removal; and, items that delay the FDA review process.
According to the FDA official, firms are typically placed on import alert if one of the following scenarios takes place: (1) the firm had an FDA inspection where a Form FDA 483 (483) was issued and the firm did not respond to the 483 within the stipulated timeframe; (2) the firm responded to the 483 in a timely manner, but the evidence submitted did not appropriately correct the deficiencies noted, after which, a warning letter was issued and firm did not respond to the warning letter in a timely manner or the response did not appropriately address the deficiencies; and (3) the FDA issued a warning letter based on the review of the firm’s HACCP plan where no facility inspection took place and the firm does not respond to the warning letter in a timely manner or the response does not appropriately address the deficiencies.
The FDA official stated that firms should submit the following evidence/documentation when requesting removal from Import Alert 16-120: at least five (5) days of monitoring records; a revised HACCP plan; a Hazard Analysis (optional); and the process flow with CCPs clearly identified. Typically, analytical samples are not required as evidence for removal from Import Alert 16-120. The FDA official indicated that, in most cases, FDA will advise the firm not ship any products while on Import Alert 16-120.
The FDA official discussed issues that often delay the review process, such as the volume and complexity of the evidence submitted; firms that continuously submit new information; or submitted information that is poorly organized. Interestingly, the FDA official indicated that consultants typically provide better organized submissions compared to most food importers. Such well-organized petitions typically move more quickly and more successfully through FDA’s process.
Registrar Corp helps companies with U.S. FDA regulations. For FDA detention assistance, preparing an FDA petition, and other FDA-related matters, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.