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

Source: https://www.keypedia.com/records/483/glicerinas-industriales-sa-de-cv/5e64d372-5822-42a5-9585-343b683f47be

> FDA 483 for Glicerinas Industriales, S.A de C.V on May 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glicerinas Industriales, S.A de C.V
- Inspection Date: 2023-05-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Retired](https://www.keypedia.com/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)

Company: https://www.keypedia.com/companies/glicerinas-industriales-sa-de-cv/32b811a4-286b-4206-9e3f-63152e3387ee

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1