483
PAI Holdings, LLC. dba Pharmaceutical Associates IncPAI Holdings, LLC. dba Pharmaceutical Associates Inc – FDA 483, Aug 2, 2023
Record Details
PAI Holdings, LLC. dba Pharmaceutical Associates, Inc in Greenville, SC, was cited for significant deficiencies during an FDA inspection from July 24 to August 2, 2023. Observations included failures in equipment calibration, work order initiation for identified issues, and concurrent documentation practices. Additionally, the firm lacked adequate written procedures for cleaning and maintenance schedules, leading to conditions like rust on manufacturing equipment.
- Inspection date
- August 2, 2023
- Product type
- drugs
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ID · 10de477d-5448-4f04-952c-cb08bd0d77ea
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