# FDA 483 - Laboratoires Druide inc. - February 14, 2025

Source: https://www.globalkeysolutions.net/records/483/laboratoires-druide-inc/6463af78-39da-452a-a8b0-7256dceabafe

> FDA 483 for Laboratoires Druide inc. on February 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratoires Druide inc.
- Inspection Date: 2025-02-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Laboratoires Druide inc., an OTC drug manufacturer in Pointe-Claire, received an FDA Form 483 citing significant deficiencies across its quality system. Observations included inadequate equipment design and maintenance, failure to verify raw material identity, lack of process validation, and insufficient employee training. These issues indicate a systemic failure to adhere to cGMP requirements, potentially impacting the quality and safety of their drug products.

## Related Documents

- [WARNING_LETTER - 2025-02-14](https://www.globalkeysolutions.net/records/warning_letter/laboratoires-druide-inc/b491e200-d716-44ed-85d9-e88d6261e0e5)

## Related Officers

- [WenNing Chan](https://www.globalkeysolutions.net/people/wenning-chan/973bf578-405d-46cf-b09e-254d6db07c08)
- [Mathematical statistician](https://www.globalkeysolutions.net/people/wen-ning-chan/e1f71810-6994-4474-876f-699ea9dee32c)

Company: https://www.globalkeysolutions.net/companies/laboratoires-druide-inc/c8413bdf-7483-4f6f-a33d-34626ac68672

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