483
PPL Healthcare LLCPPL Healthcare LLC – FDA 483, May 8, 2026
Record Details
PPL Healthcare LLC in Sellersville, PA, was cited with three observations during an FDA inspection. The firm failed to establish adequate specifications for incoming API, leading to undetected contamination in drug products. Additionally, the inspection revealed a lack of proper sanitation for manufacturing equipment, resulting in microbial contamination, and a failure to consistently follow the written stability testing program.
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ID · 93012da2-4b9a-4698-830a-fc06d13bcff2
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