New Jersey, Arizona Compounders Land Warning Letters for Sterility Concerns
Two more drug compounders have landed FDA warning letters over sterility deficiencies at their facilities.
Agency inspectors cited Millers of Wyckoff for distributing adulterated and misbranded products following a June 2015 inspection.
According to the warning letter, inspectors saw an operator forget to disinfect materials introduced to the ISO 5 area and re-use a laboratory coat after it fell on the floor, potentially exposing drug products to contamination.
Additionally, certification reports indicated that the pressure differential from the anteroom to an unclassified area did not meet the minimum pressure differential requirements. Inspectors also concluded that the firm had not conducted studies showing that its ISO 5 areas were sterile.
Other GMP violations include the facility’s failure to establish and follow written procedures to prevent microbiological contamination and its inability to ensure that manufacturing personnel wear sterile garments.
Finally, the New Jersey-based facility was cited for producing compounded drugs without first receiving a valid prescription, a failing that also rendered some of its products misbranded.
Edmond, Okla.-based Qualgen also received a warning letter, this one accusing the outsourcing facility of producing adulterated, misbranded and unapproved products.
According to the warning letter, an inspection between August and September of 2015 showed that the ceiling tiles of the facility’s ISO 7 clean rooms were not fully sealed, allowing unfiltered air to enter the cleanrooms.
Seven of the GMP violations related to the production of unadulterated products. For instance, the inspectors found that the facility had neither written procedures to prevent microbiological contamination nor protocols designed to assess the stability characteristics of drug products. The remaining violations concerned sterility assurance.
The facility also was dinged for producing unapproved products due to the absence of FDA-approved applications on file for its drug products. Agency inspectors also noted the outsourcing facility failed to submit reports to the FDA identifying the products it compounded six months prior.
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