Contact us 24/7
View all

FDA Observes Serious Issues at Teva Pharmaceuticals Plant

Destiny Baker3 years ago

According to FDA News, Teva Pharmaceuticals has been issued a Form 483 after investigators observed unsatisfactory conditions in the company’s Sellersville, Pennsylvania plant.

What Is a Form 483?

  • A Form 483 is issued by the FDA after investigators observe conditions or behaviors that violate the Food Drug and Cosmetic Act.
  • After a Form 483 is issued, company managers must meet with investigators to discuss the violations before writing an action plan for resolving the each observation.
  • Past Form 483s are considered when the FDA deliberate pursuing legal action against a company.

Teva Pharmaceuticals Receives Form 483

  • During a recent investigation of a Teva Pharmaceutical plant in Sellersville, Pennsylvania, investigators cited 6 observations that violated the Food Drug and Cosmetic Act.
  • According to the FDA, Teva failed to perform testing of reserve samples from a batch of a drug that was flagged as lacking effectiveness.
  • Teva had continued to use a pump skid to make methylphenidate despite the skid being under quarantine due to a failed cleaning verification.
  • The plant was also cited for improper cleaning procedures including investigators finding drug residue in equipment that had undergone major cleaning beforehand.
Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

HAVE YOU BEEN INJURED?

If you’ve been injured, we can help. Contact us