# FDA 483 - Miramar Cosmetics, Inc - August 31, 2022

Source: https://www.keypedia.com/records/483/miramar-cosmetics-inc/5c75a508-33b6-4149-a949-8443f9a14478

> FDA 483 for Miramar Cosmetics, Inc on August 31, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Miramar Cosmetics, Inc
- Inspection Date: 2022-08-31
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Miramar Cosmetic Inc, a dietary supplement distributor in Doral, FL, received eight observations during an FDA inspection. The firm demonstrated significant deficiencies, primarily a widespread lack of written procedures for critical operations including quality control, packaging, labeling, holding, distribution, handling returned products, and investigating complaints. Additionally, the inspection noted issues with untrained personnel and the failure to collect required reserve samples.

## Related Officers

- [Benita C. Okeke](https://www.keypedia.com/people/benita-c-okeke/1c62b9fb-4cc6-4d6b-966c-98b471d850e4)
- [Ivis L. Negron Torres](https://www.keypedia.com/people/ivis-l-negron-torres/eb77f360-bb0b-4a13-a0da-b89c36ccaca9)

Company: https://www.keypedia.com/companies/miramar-cosmetics-inc/a86f9854-c82f-4ac2-abe6-1ddc153fa180

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6