FDA Hits Valeant’s Bausch & Lomb With Form 483

Regulatory NewsRegulatory News | 06 September 2016 |  By 

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 for Valeant’s Bausch & Lomb sterile drug manufacturing facility in Tampa, FL, citing the site for microbiological contamination of drugs purporting to be sterile.

The eight-day inspection last February uncovered four observations detailing:

  • Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up
  • Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed
  • Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product
  • Control procedures are not established to monitor the output of the manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

FDA’s Michael Tollon said in the report that he found “non-viable particles exceeding action limits on aseptic filling lines used in the manufacture of several eye drop solutions, including Latantoprost Ophthalmic Solution (0.005%), Opcon-A, Ketotifen Fumarate Ophthalmic Solution (0.025%) and Tobramycin Ophthalmic Solution, USP (0.3%).

Bausch & Lomb’s investigations into the nonconformities also were found to be incomplete and potential root causes were not always identified, with some excursions attributed to a bottle and bottle component “without scientific justification.” Valeant did not respond to a request for comment.

Valeant Troubles

The release of the Form 483 for Bausch & Lomb comes more than three years since Valeant acquired the company for $8.7 billion in 2013, then laid off a couple thousand of its employees, and more recently, some are calling on Valeant to sell the company to pay off debt.

Those calls to sell Bausch came a month before the Senate Special Aging Committee revealed last May that Valeant jacked up the prices of a number of drugs by as much as 6,000%.



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