483
PEL Healthcare LLCFDA 483 - PEL Healthcare LLC - May 08, 2026
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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