483
Welch, Holme & Clark Co., IncWelch, Holme & Clark Co., Inc – FDA 483, Jul 10, 2024
Record Details
An FDA inspection of Welch, Holme & Clark Co., Inc. in Newark, NJ, revealed significant deficiencies in their quality control unit. Observations included a lack of appropriate controls over computerized systems, inadequate written procedures for quality control responsibilities and external lab qualification, and insufficient CGMP training for laboratory personnel. These issues indicate a serious lack of oversight in critical areas of their repacking operations.
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ID · 9217c5c1-558a-47cc-b88c-216c93ff20ff
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