# FDA 483 - Phase 4 Pharmaceutical Llc - May 02, 2017

Source: https://www.keypedia.com/records/483/phase-4-pharmaceutical-llc/9e31fe2a-c8cd-4313-9409-3dc88de07b8f

> FDA 483 for Phase 4 Pharmaceutical Llc on May 02, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phase 4 Pharmaceutical Llc
- Inspection Date: 2017-05-02
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Phase 4 Pharmaceutical Llc, a drug repackager and relabeler in Aventura, FL, was inspected by the FDA. The inspection revealed significant deficiencies in written procedures and quality control unit responsibilities for transdermal drug products. These issues indicate a lack of adequate controls over manufacturing, warehousing, distribution, complaint handling, and returned products.

## Related Documents

- [WARNING_LETTER - 2017-05-02](https://www.keypedia.com/records/warning_letter/phase-4-pharmaceutical-llc/c5948653-912a-479d-9a71-62886bb84c5a)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/phase-4-pharmaceutical-llc/c38543ce-01d5-494d-8d37-5ec2658ce067

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