# FDA 483 - Emballages Spectrum Inc. - November 06, 2025

Source: https://www.globalkeysolutions.net/records/483/emballages-spectrum-inc/921a3191-4917-47f5-949c-a8c90f137ebf

> FDA 483 for Emballages Spectrum Inc. on November 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emballages Spectrum Inc.
- Inspection Date: 2025-11-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Spectrum Packaging Inc., a drug packager and labeler in Montreal, revealed three significant observations. The firm was cited for failing to adequately qualify packaging equipment, lacking established written procedures for production and process controls, and not demonstrating appropriate cleaning methods for equipment. These issues indicate deficiencies in ensuring drug product quality and compliance with cGMP regulations.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.globalkeysolutions.net/companies/emballages-spectrum-inc/b81fd150-a4f8-4e8c-a8bc-f6c253da2262

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8