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FDA Observes Serious Issues at Teva Pharmaceuticals Plant
September 9th, 2013 thomasjhenry by thomasjhenry
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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