FDA Observes Serious Issues at Teva Pharmaceuticals Plant

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.

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