# FDA 483 - Respect Manufacturing Corporation - January 13, 2025

Source: https://www.keypedia.com/records/483/respect-manufacturing-corporation/0bff34a0-a653-4e62-b5f0-a673cb15c139

> FDA 483 for Respect Manufacturing Corporation on January 13, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Respect Manufacturing Corporation
- Inspection Date: 2025-01-13
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Respect Manufacturing Corporation in Denver, CO, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality unit, equipment validation, batch record keeping, and process validation for its OTC drug products. These issues indicate a lack of robust controls over critical manufacturing and quality processes.

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

Company: https://www.keypedia.com/companies/respect-manufacturing-corporation/d2d5dea3-d42b-4056-b352-b8f2afc723ca

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face