FDA 483 - d&d pharma, llc - July 17, 2019

This FDA Form 483 documents observations from an inspection, indicating deficiencies in product evaluation and equipment calibration. The facility failed to adequately evaluate products and take remedial action following actionable microbial contamination in the ISO 5 classified aseptic processing area during aseptic production.

Specifically, environmental sampling on May 30, 2019, revealed: * 1 cfu/m3 of *Geotrichum sp.* during fungal air testing in an ISO 5 laminar flow hood (location: (b)(4)). * 1 cfu of a non-sporulating fungus on a fungal contact plate in an ISO 5 laminar flow hood (location: (b)(4)).

Several employees confirmed that a retrospective investigation into potentially affected lots produced in these hoods was not performed.

Additionally, the facility failed to perform (b)(4) testing to the (b)(4). The gauge used to measure pressure on the (b)(4) tester was last calibrated on October 26, 2017. This uncalibrated gauge was observed in use during a (b)(4) test of a (b)(4) for lot number 07082019%33@3, product ESCO1: epinephrine HCl (PF/SF)/lidocaine HCl (PF) in BSS 0.025%/0.75%. These observations highlight issues with quality control, environmental monitoring, and equipment maintenance, potentially