FDA 483 - avella of deer valley, inc. - July 29, 2015

The FDA inspection of a facility producing sterile drug products identified several deficiencies. The firm's environmental monitoring program for ISO 5 hood and ISO 7 clean rooms, as outlined in SOP 03 S-05, version 4, is deficient. Non-viable particle monitoring, viable air sampling for fungus and bacteria, and surface/environmental sampling are not performed daily as required, but rather at an unspecified frequency.

SOP 03 S-04, version 4, regarding aseptic personnel monitoring, also shows deficiencies. Fingertip sampling is not conducted at the required frequency, and body sampling is performed in the 503A pharmacy instead of the actual monitoring location.

Furthermore, the facility's cleaning procedures for aseptic areas are inadequate. SOP 03 S-04, version 1, and SOP 03 S-02, version 5, lack requirements for cleaning chairs used in aseptic labs. An observation on 7/21/2015 noted a technician manufacturing sterile drug product while sitting on a non-impervious, difficult-to-clean chair, with no cleaning SOP or log for these chairs.

Finally, several drug product labels and container labels, including Budesonide/Tobramycin, Progesterone, Bumetanide, Leuprolide Acetate, Mepivacaine, Oxytocin, Bupivacaine/Fentanyl, and Bevacizumab, are missing information required by sections