Form 483

EBI Patient Care, Inc. Form 483, 2018-01-17

FDA issued a Form 483 to EBI Patient Care, Inc. on 2018-01-17 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

EBI Patient Care, Inc. · Guaynabo, United States · Issued January 17, 2018

Overview

2 public-safe observations are available for this inspection.
2 structured CFR citations are represented.
3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Jan 2018

21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Nydia E Colon, Abby E Pelletier, Laiza V Garcia

17 Jan 2018

21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Nydia E Colon, Abby E Pelletier, Laiza V Garcia

Inspected site

EPEBI Patient Care, Inc.Guaynabo, United States

Inspection team

NENydia E Colon

AEAbby E Pelletier

LVLaiza V Garcia

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 820.100(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.75(a)	Cited across public-safe Form 483 observations	1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

The site's full inspection history around this Form 483
Whether these citations escalated to a warning letter
The investigators involved and the citations they repeat elsewhere