Alisa Aija Karlsons

Practice Details

• Languages
  Latvian
• Firm Information
  Position

  Partner

  Firm Name

  Keller and Heckman LLP
• Representative Cases & Transactions
  Cases

  Representative Matters: Successfully filed numerous Food Contact Notifications (FCNs) on a range of packaging substrates
  applications
  Advised food packaging producers on performing self-determined Generally Recognized as Safe (GRAS) evaluations as a means of establishing FDA compliance of new product lines
  Determined 21 C.F.R. 176.170 FDA regulatory compliance of an entire line of paperboard produced by a major foreign paperboard manufacturer, allowing the manufacturer to enter the U.S. market
  Counseled a large food contact material manufacturer through a contamination event to minimize risk
  supply chain disruptions
  Advised food packaging producers on California's Proposition 65, including overseeing development of No Significant Risk Levels (NSRLs)
  Maximum Allowable Dose Levels (MADLs),
  established exemptions from warning requirements
  Assisted PET recyclers in establishing the food-contact compliance of their recycled PET
  obtaining no objection letters (NOLs) from FDA
  Drafted FDA compliance opinions to assist companies in obtaining certification from NSF
  Filed petitions with the European Food Safety Authority (EFSA)
  U.K.'s Food St
  ards Agency (FSA) to clear new plastic materials under the Plastics Regulation
  Guided a major polymer producer in communications with customers
  conducted a risk assessment of non-intentionally added substances (NIAS) under the EU's Plastics Regulation
  Advised a leading manufacturer of coatings on compliance obligations
  customer assurance language following implementation of the EU'S BPA Regulation
  Counseled clients on good manufacturing practice (GMP) considerations, including conducting GMP audits of client facilities
  Prepared
  submitted Drug Master Files (DMFs) to FDA on packaging materials for drug products