483
Romark Global Pharma, LLCRomark Global Pharma, LLC – FDA 483, Apr 27, 2020
Record Details
An FDA inspection of Romark Global Pharma, LLC in Manati, PR, revealed significant deficiencies in preventing microbiological contamination in drug products, particularly NT-300 tablets. The firm's procedures for manufacturing, equipment cleaning, and quality control were found to be inadequate, leading to product rejections and a high risk of contamination. These issues indicate a systemic failure in maintaining a state of control over microbial quality.
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ID · 3e58583d-d809-4d01-8213-4fef17485fe7
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