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FDA Seeks Comments on Criteria Changes for Detaining Imported Food, Including Supplements

November 14, 2011 By Steven Perez

FDA seeks comment on FSMA
FDA is seeking public comment on changes to FSMA

FDA is seeking public comment on changes to criteria for detaining food at the point of import.

Enacted in January of this year, the Food Safety Modernization Act (FSMA) changed the administrative detention criteria originally bestowed on FDA by the Bioterrorism Act of 2002, which allowed the agency to “detain any article of food if, during an inspection, examination, or investigation, an FDA officer or qualified employee finds there is credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.” [Read more…]

Filed Under: All Services, Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links, Nutraceutical Links Tagged With: detention, FDA, food, food safety, FSMA, import

Chinese seafood exports to face more scrutiny?

October 21, 2011 By Steven Perez

Expect more food shipments from China to the United States to face examination and potentially detention as the U.S. Food and Drug Administration implements the new Food Safety Modernization Act (FSMA), according to Benjamin England, a 17-year FDA veteran and founder and CEO of FDAImports.com and ExportToUsa.com.cn.

On Wednesday, England listed the three major challenges facing Chinese food exporters ahead of the China Fisheries; Seafood Expo, which takes place in Qingdao, China, from 1 to 3 November.

One of the three major challenges is juggling speed and quality control. “One of the toughest parts about FDA compliance from a manufacturing standpoint is that there’s always a tension between speed and quality control,” said England.

To stay competitive, Chinese companies are producing more at a faster rate. “When you do that month after month there is a risk that quality control is diminished,” he said. “because the rules are getting more complicated and production outpaces your ability to stay on top of it.” [Read more…]

Filed Under: All Services, Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links Tagged With: Analytical, detention, exports, FDA, food safety, guidance, industry, products, Testing

U.S. ‘Re-inspection’ Fee Now in Effect

October 3, 2011 By Steven Perez

A new U.S. fee that is expected to significantly increase the cost of re-inspecting product suspected of a food-safety violation went into effect on Saturday.

As a result, the U.S. Food and Drug Administration has issued some clarification and relief on the collection of these fees, authorized under the Food Safety Modernization Act, which was signed into law by President Obama in early January.

The FDA will begin charging food importers a fee, based on an hourly rate, for any “re-inspection” of product, which is required when the FDA discovers a food-safety violation during an inspection. The fee is USD 224 per hour, USD 335 per hour if foreign travel is required.

The National Fisheries Institute on Saturday e-mailed an alert to its industry members summarizing the FDA’s guidance. And, to the relief of U.S. seafood importers, the FDA does not intend to bill any companies before 1 January, 2012, and fees will not be assessed if the original inspection or recall order occurred before 1 October, 2011. [Read more…]

Filed Under: All Services, Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links Tagged With: analysis, detection, detention, FDA, food safety, guidance, imported, products, seafood, shrimp, violation

ISO/IEC 17025 ACCREDITED

ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories”. ISO/IEC 17025 is a general umbrella term used to refer to the specific standard; the current version of this standard is ISO/IEC 17025:2017. The standard contains two main sections: management requirements (primarily related to the operation and effectiveness of the quality management system within the laboratory) and technical requirements (primarily related to the competence of staff and calibration of equipment). The standard also gives requirements related to quality management such as document control and corrective action. This standard is the basis for accreditation from an accrediting body.

ADPEN has also been inspected by the US-EPA and US-FDA multiple times with no observations.

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ADPEN Laboratories, Inc.
11757 Central Parkway
Jacksonville, FL 32224 USA

Phone: 1.904.645.9169
Fax: (904) 641-8423
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