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483
•Glicerinas Industriales, S.A de C.V•May 12, 2023

Glicerinas Industriales, S.A de C.V – FDA 483, May 12, 2023

Record Details

Glicerinas Industriales, S.A de C.V, a repackager/relabeler in Zapopan, Jalisco, Mexico, was cited during an FDA inspection for failing to thoroughly investigate unexplained discrepancies. Specifically, the firm did not investigate numerous batches of product found to contain various particles like insects, hair, and fabric. This indicates a significant quality control issue regarding product purity and batch record review.

Company
Glicerinas Industriales, S.A de C.V
Inspection date
May 12, 2023
Product type
drugs
Office
Office of Biological Products Operations - Division I
People
  • Khoa Nathan V. Tran (issuing_officer)
  • Ariel Cruz Figueroa (Retired)
View Company Profile

ID · 5e64d372-5822-42a5-9585-343b683f47be

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