0 Firm

[Rell Jette]

WhiteCase is an international law firm that serves companies, governments and financial institutions. Our long history as a global firm means we are uniquely placed to help our clients resolve their most complex legal challenges wherever they are.

Global law firm White & Case LLP has ranked among the most diverse law firms in The American Lawyer's annual Diversity Scorecard. This achievement marks the 17th consecutive year the Firm has been featured in the top 10. Learn More > 10 July 2024 White & Case climbs five spots in UK M&A Legal Advisor rankings for H1 2024 White & Case has significantly advanced in the UK M&A Legal Advisor rankings for H1 2024, climbing five spots to #7. Law firms are ranked by deal value based on the latest data from LSEG.

Notice: We appreciate your interest in Latham & Watkins. If your inquiry relates to a legal matter and you are not already a current client of the firm, please do not transmit any confidential information to us. Before taking on a representation, we must determine whether we are in a position to assist you and agree on the terms and conditions of engagement with you. Until we have completed such steps, we will not be deemed to have a lawyer-client relationship with you, and will have no duty to keep confidential the information we receive from you. Thank you for your understanding.

For decades, we have been intentional and consistent in our efforts to increase the diversity of our workforce and to advance the values of diversity and inclusion in the legal profession. Today, we are a far more diverse firm than ever before. We take pride in that diversity, and we see it as a core strength of our firm. It is key to our culture, our values, and our business strategy. It is fundamental to the way we connect with and serve our clients.

As we consider the Supreme Court decision limiting the consideration of race in university admissions, we re-affirm our commitment to building a more diverse and inclusive workplace and legal profession. Our methods for fulfilling that commitment may evolve over time as the legal landscape changes; our commitment will remain steadfast.

Listen to Perkins Coie lawyers discuss a range of timely legal topics and interview renowned thought leaders for valuable insights. They address insurance coverage, labor and employment, virtual mediation, white-collar defense, and innovative patent strategies in our diverse podcast series.

From developments related to virtual currencies and wage-and-hour issues to trends in food litigation and privacy and data security law, our blogs offer timely information and insights on a range of topics affecting businesses.

FEI is an acronym which stands for FDA Establishment Identifier. It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA regulated products.

Address information can be used to distinguish locations since each location will display a separate firm profile. If no matches on name or FEI are found, this indicates that no applicable compliance records are present for the firm.

Three FDA FSMA rules (Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals) require that importers and facilities perform certain risk-based activities to verify that their suppliers are meeting applicable U.S. food safety standards. Under these rules, you must evaluate, among other things, the applicable FDA food safety regulations and information relevant to the supplier's compliance with those regulations, including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety, and document the evaluation.

Warning letters are considered advisory actions and the agency position is that Warning Letters are issued only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act). The use of Warning Letters is based on the expectation that most individuals and firms will voluntarily comply with the law. Warning Letters issued to individuals and firms can be found on the Warning Letter page.

The Warning Letter page allows users to search letters issued during specific calendar years spanning the last 10 years as well as allowing a simple search where a user can enter in terms and an advanced search where a user can search on particular fields such as company name, the date range the letter was issued in, issuing FDA office, subject, if a response letter has been posted, or if a closeout letter has been posted. The page also has several browse functions where you can search just by company name or display a list of warning letters that have certain criteria, such as those that have close out letters.

Detention without physical examination of products being imported in the country (as described in the Regulatory Procedures Manual section 9-6) is appropriate when there exists a history of the importation of violative products, or products that may appear violative, or when other information indicates that future entries may appear violative.

Detentions without physical examination are implemented through Import Alerts which indicate the country/area or firm and the specific product from the country/area or from the firm that is to be detained without physical examination. More information on import alerts can be found on the Import Alerts page.

The enforcement report allows the searching of classified recalls in a consolidated report of recalls classified in a weekly period of time and an advanced search which allows searching of specific fields associated with the recall such as firms, products, and classification.

Along with the Enforcement Report, there are also resources that can be used to look at press releases for certain recalls, market withdrawals and safety alerts. The information found on this site is gathered from press releases and other public notices about certain recalls of FDA-regulated products and may include photos and other documents along with the press release. Not all recalls have press releases or are posted on this page.

FDA can detain a regulated product that appears to be out of compliance with the Act. In such a situation the FDA district office will issue a "Notice of FDA Action" specifying the nature of the violation to the owner or consignee. The owner or consignee is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product. If the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another "Notice of FDA Action" refusing admission to the product. The product then has to be exported or destroyed within 90 days. FDA posts what products have been refused and the reason to the Import Refusal Report.

The Import Refusal Report is updated monthly and can be searched by country/area or product for a given month and year. Users can also download the refusal data for different periods in comma separated values (csv) format.

FDA discloses inspection information on the Inspections Database page and is updated monthly. This database does not represent a comprehensive listing of all conducted inspections. For this data set, FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. The disclosure of this information is not intended to interfere with planned advisory or enforcement actions, and some information may be withheld from posting until such action is taken.

Inspections are classified based upon findings identified during an inspection and Agency review for compliance and typically have either a classification of NAI (no action indicated), VAI (voluntary action indicated), or OAI (official action indicated). The latter OAI classification, though the worst classification, does not mean that an advisory or enforcement action will be taken. It is important to note that an OAI classification may be due to reasons other than food safety, for example issues with nutritional or ingredient labeling may result in an OAI classification.

Inspections can be searched using several fields such as the firm name, project area, the date the inspection ended, and classification. The inspections can also be downloaded as an xlsx file. As noted above, this database (and therefore the results) does not represent a comprehensive listing of all conducted inspections and is updated monthly.

An OAI classification may result in an action taken by FDA, so it is important to check if the firm has been sent a Warning Letter (see the Warning Letters section above) or been subject to other actions (see the Other Compliance Resources section below).

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In a rapidly changing world, having the right legal partner makes a vital difference. At Greenberg Traurig, we help clients master uncertainty through proactive legal strategies, skilled counsel, and access to vast resources worldwide.

As the world reacts to the crisis in Ukraine, Greenberg Traurig is here to advise our clients on issues involving sanctions, international trade, cybersecurity, and other legal ramifications. We are also using our resources to provide significant coordinated pro bono legal services and humanitarian aid to support those impacted.

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