# FDA 483 - Max Chemical Inc - March 15, 2024

Source: https://www.keypedia.com/records/483/max-chemical-inc/4ef58472-bc06-43a5-8f13-f628027056b5

> FDA 483 for Max Chemical Inc on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Max Chemical Inc
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Max Chemical Inc. in San Juan, PR, a human drug manufacturer of Isopropyl Alcohol 70% and Hand Sanitizer, was cited with six observations during an FDA inspection. The firm demonstrated significant deficiencies across multiple quality systems, including inadequate equipment validation, a non-independent quality unit, insufficient raw material testing, and a lack of stability testing and proper product release procedures. These issues indicate a broad failure to adhere to current Good Manufacturing Practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Mabany Lizardi](https://www.keypedia.com/people/mabany-lizardi/adcca71c-e996-44e5-9827-d1aa2773e832)

Company: https://www.keypedia.com/companies/max-chemical-inc/622c32f0-42a1-4ae4-aeee-bd9125f0ed89

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