FDA slaps warning letter on Minnesota API facility after employee destroys cleaning log
A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.
One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.
“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”
The site also failed to demonstrate that it was properly cleaning its facility, according to FDA.
“During your API repackaging and relabeling operations, including highly potent drugs such as testosterone, estradiol, betamethasone, tamoxifen and opioids, your firm failed to conduct adequate cleaning validation studies to demonstrate that your cleaning procedures for your non-dedicated “cabins” (production rooms) are adequate to prevent potential cross-contamination,” the letter says.
The letter also stated that an employee destroyed a log on when cleaning at certain parts of the site occurred, and the firm was unable to provide a copy to investigators.
“Investigators also observed that the cleaning log for Cabin (b)(4) was (b)(4) during repackaging of lidocaine HCl, even though the cleaning activities had not been initiated. You later stated that an employee destroyed the cleaning log and were unable to provide a copy to our investigators,” the letter says.
The FDA also found the company’s response inadequate because of a failure to demonstrate that cleaning procedures were able to prevent cross-contamination of repackaged API.
Another major observation identified is the plant failed to adequately investigate and document out-of-specification results and correct these actions.
For example, the letter states that the company did not initiate an investigation into OOS bioburden counts from its water system, which is used as a drug component and no investigation was launched into water test results.
Additionally, the company’s quality unit failed to perform several critical functions to ensure that repacked APIs meet CGMP requirements. For example, investigators observed computers connected to cGMP-related laboratory equipment allowed changes to or deletion of data generated to support the release of drugs without restriction.
Furthermore, during the inspection, the company acknowledged that its quality unit did not qualify for the contract laboratories it used to support product releases due to resource issues.
The FDA recommended that these procedures be fixed as soon as possible, and the company had 15 days from June 14 to respond to the letter. Failure to address any of these deviations may cause the FDA to withhold the issuance of export certificates or approval of any new applications or supplements listing Fagron as a drug manufacturer until any deviations are completely addressed and confirm compliance. A re-inspection may also be on the cards.
Endpoints News reached out to Fagron for comment but has not yet received a response to the inquiry.
