Form 483

Hudson Respiratory Care Tecate S. de RL de CV Form 483, 2012-01-12

FDA issued a Form 483 to Hudson Respiratory Care Tecate S. de RL de CV on 2012-01-12 with 2 public-safe observations.

483· Form 483 issued2 observations

Hudson Respiratory Care Tecate S. de RL de CV · Tecate, Mexico · Issued January 12, 2012

Overview

2 public-safe observations are available for this inspection.
2 structured CFR citations are represented.
1 investigator is tied to this Form 483.

Inspectional observations

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

12 Jan 2012

21 CFR 820.70(a)

Process control procedures, Lack of or inadequate procedures

Cited by Catherine J Laufmann

12 Jan 2012

21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Catherine J Laufmann

Inspected site

HRHudson Respiratory Care Tecate S. de RL de CVTecate, Mexico

Inspection team

CJCatherine J Laufmann

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 820.70(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