www.fdanews.com/articles/192127-non-sterile-drugmaker-hit-for-inadequate-cleaning
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Non-Sterile Drugmaker Hit for Inadequate Cleaning
July 25, 2019
The FDA cited non-sterile drug manufacturer PrecisionMed for ineffective cleaning to prevent cross-contamination of products at its Tampa, Florida facility.
The agency investigator cited the facility in a Form 483 for failing to properly clean work surfaces and utensils between batches.
The firm also failed to document cleaning procedures after manufacturing a highly potent drug compound, before producing a non-hazardous drug compound on the same equipment.