Perma Pure LLC is in dutch with the Food & Drug Administration again.
The Toms River, N.J.-based company, which makes equipment to analyze gas streams, first made the watchdog agency’s list after inspections in 2006 revealed problems with its quality assurance systems and procedures.
Four years later those problems haven’t been addressed, at least according to a Sept. 21 letter from the FDA to Perma Pure president Richard Curran. Citing a 12-day FDA inspection in August, New Jersey district director Diana Amador-Toro wrote that the company had failed to correct the problems in the intervening years.
"For example, although management reviews were conducted, they failed to detect that seven of eight quality system deficiencies cited during the previous inspection in July 2006 had not been corrected even though a written commitment for corrective actions, dated August 31, 2006, was submitted," Amador-Toro wrote. "Your September 3, 2010 response is not considered to be adequate. No revised procedure was provided. Corrective actions for subsequent observations list the increased number of management review meetings and agenda items as a means of preventing “recurrence of incomplete follow-through of non-conforming conditions.” There is no assurance that the proposed actions for management reviews will result in a satisfactory review of the quality system regarding overall compliance with the Quality System regulations and your internal quality policy and objectives."
Perma Pure has 15 working days from receipt of the letter to let the FDA know how it plans to correct the problems.
"Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice," Amador-Toro wrote. "These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all warning letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices, to which the Quality System regulation deviations are reasonably related, will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected."
