483
Blaine Labs IncBlaine Labs Inc – FDA 483, Dec 15, 2023
Record Details
Blaine Labs Inc, a manufacturer in Santa Fe Springs, CA, was inspected and received a Form 483 with four repeat observations. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of critical procedures, incomplete validations, and unqualified equipment. Additionally, the firm failed to validate manufacturing processes and store drug products under appropriate temperature conditions.
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ID · b1bb20b9-80ff-4191-913c-8c61d3c832b7
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