483
Pharmaceutics International IncPharmaceutics International Inc – FDA 483, Dec 6, 2024
Record Details
Pharmaceutics International Inc in Hunt Valley, MD, was inspected and received a Form 483 with four observations, two of which were repeat observations. The inspection revealed deficiencies in equipment cleaning validation, supplier qualification for API microbiological testing, instrument calibration procedures for HPLC systems, and overall equipment qualification and control. These issues indicate significant concerns regarding the firm's quality control and manufacturing processes.
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ID · e2e84415-5d23-4319-901b-b9bbb7761500
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