FDA 483 - PAI Holdings, LLC, dba Pharmaceutical Associates, Inc
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Vista Pharm, a manufacturer and re-packager of drug products in Largo, FL, was cited for significant deficiencies during an FDA inspection. Observations included failures in written procedures for cleaning and maintenance, specifically regarding sampling point identification, documentation of activities, and timely completion of maintenance. Additionally, the firm failed to follow established test procedures and laboratory control mechanisms, leading to issues with sample protection and microorganism identification.
- Product Type
- Drugs
ID · ced132fd-1cf6-46e4-9ca3-1730248290b7