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483
•American Spraytech LLC•April 11, 2024

American Spraytech LLC – FDA 483, Apr 11, 2024

Record Details

American Spraytech LLC, a contract manufacturer in Branchburg, NJ, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection cited the firm for failing to adequately establish procedures for controlling nonconforming product during manufacturing. Additionally, the firm's corrective and preventive action system was found to be inadequate, lacking proper analysis of quality data and thorough investigation into the causes of nonconformities.

Company
American Spraytech LLC
Inspection date
April 11, 2024
Product type
drugs
Office
New Jersey District Office
People
  • Nakesh N. Gomanie
  • Shelby N. Turner
View Company Profile

ID · c667e876-880d-43c4-93b0-b1e73f9365e7

Other documents for American Spraytech LLC
  • 483 - 2025-01-24January 24, 2025

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