# FDA 483 - Master Paints & Chemical Corp - October 17, 2023

Source: https://www.keypedia.com/records/483/master-paints-chemical-corp/f0ecfaff-a9bb-4bf9-9149-927ca169c875

> FDA 483 for Master Paints & Chemical Corp on October 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Master Paints & Chemical Corp
- Inspection Date: 2023-10-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Master Paints & Chemical Corp in Guayanilla, PR, a drug product manufacturer, revealed significant deficiencies across multiple areas of its operations. The firm failed to reject out-of-specification drug products, lacked adequate testing procedures and instrument calibration, and did not validate manufacturing processes or provide GMP training to employees. These issues indicate a systemic failure to adhere to good manufacturing practices, potentially compromising drug product quality and safety.

## Related Officers

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Company: https://www.keypedia.com/companies/master-paints-chemical-corp/a3427313-ad64-45fe-9e67-2d7bbaa6f699

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6