483
SOFIE Co. dba SOFIESOFIE Co. dba SOFIE – FDA 483, Apr 21, 2022
Record Details
SOFIE Co. dba SOFIE, a PET drug manufacturer in Morgantown, WV, was cited for failing to implement adequate procedures to ensure equipment suitability for its intended purposes. The inspection revealed deficiencies including a lack of light intensity verification for drug product inspection and the absence of written preventive maintenance programs for manufacturing equipment and aseptic manipulation units, which could adversely affect drug quality.
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ID · 45223af2-ae88-434e-9b7e-021fac6ff368
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