More FDA inspection problems plague Impax
This article was originally published in Scrip
Impax Laboratories has been struggling lately with problems at its manufacturing facilities, with the latest involving a re-inspection by the FDA that turned up at least seven issues of concern at the company's Hayward, California plant, two of which were "repeat observations."
The FDA issued a so-called 483 form, which is used by investigators to record their observations of noncompliance with current good manufacturing practices.
Shares of the firm dropped 6.4% on 4 August, before closing at $22.77, a loss of 86 cents, or 3.4%.
Just last week, Impax had been cited for 10 observations at its Taiwanese facility where the firm's investigational Parkinson's disease drug Rytary is made (scripintelligence.com, 30 July 2014).
"Addressing these latest observations and advancing our quality improvement initiatives are our top priorities," said Fred Wilkinson, president and CEO of Impax. "While the past week has been challenging, I remain enthusiastic about Impax's future and the opportunities ahead of us."
In a redacted version of the latest 483 form, which the company disclosed in a Securities and Exchange Commission filing on 4 August, the FDA said there was a failure to thoroughly review any unexplained discrepancy of whether the batch of Impax's pyridostigmine bromide tablets had been already distributed.
The FDA also said the accuracy, sensitivity, specificity and reproducibility of test methods for tamsulosin capsules had not been established and documented.
The agency also observed that written procedures for cleaning and maintenance failed to include descriptions in sufficient detail of methods, equipment and materials used and instructions for protection of clean equipment from contamination prior to use.
In addition, the FDA said appropriate controls were not exercised over computers or related systems to assure changes in master production and control records or other records were instituted only by authorized personnel.
Regulators also said the responsibilities and procedures applicable to the quality control unit were not fully followed.
And, the FDA said, buildings used in the manufacturing and holding of a drug product were not maintained in a good state of repair.
Finally, the agency said changes to written procedures were not drafted, reviewed and approved by the appropriate organizational unit.