Evanger's Dog & Cat Food Co Markham Form 483: April 2009 Observations & CFR Citations

Citation	What it covers	Cited
21 CFR 113.100(b)	Cited across public-safe Form 483 observations	4x
21 CFR 113.100(e)	Cited across public-safe Form 483 observations	3x
21 CFR 113.83	Cited across public-safe Form 483 observations	3x
21 CFR 113.89	Cited across public-safe Form 483 observations	3x
21 CFR 110.35(c)	Cited across public-safe Form 483 observations	2x
21 CFR 113.60(c)	Cited across public-safe Form 483 observations	2x
21 CFR 108.35(c)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 108.35(c)(2)(ii)	Cited across public-safe Form 483 observations	1x
21 CFR 108.35(d)	Cited across public-safe Form 483 observations	1x
21 CFR 110.20(a)(1)	Cited across public-safe Form 483 observations	1x
21 CFR 110.20(a)(3)	Cited across public-safe Form 483 observations	1x
21 CFR 110.20(b)(7)	Cited across public-safe Form 483 observations	1x
21 CFR 113.100(f)	Cited across public-safe Form 483 observations	1x
21 CFR 113.40(a)(1)(v)	Cited across public-safe Form 483 observations	1x
21 CFR 113.40(a)(12)	Cited across public-safe Form 483 observations	1x
21 CFR 113.40(a)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 113.40(a)(2)(iii)	Cited across public-safe Form 483 observations	1x
21 CFR 113.40(a)(4)	Cited across public-safe Form 483 observations	1x
21 CFR 113.40(a)(9)	Cited across public-safe Form 483 observations	1x
21 CFR 113.60(a)(1)	Cited across public-safe Form 483 observations	1x
21 CFR 113.81(a)	Cited across public-safe Form 483 observations	1x
21 CFR 113.87(d)	Cited across public-safe Form 483 observations	1x

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Evanger's Dog & Cat Food Co Form 483, 2009-04-15

Overview

Inspectional observations

Process filing

Process change reporting to CFSAN

Notify FDA - spoilage

Harborage areas

Drainage

Screening

Insecticides/rodenticides

Lack of effective pest exclusion

TID bleeder location - steam flow

Present each retort, accurate

Adjusted to agree with TID

Steam controller

Suitable material

Timing before vent, before temperature reached

Recording of teardown examinations

Coding - no mark, permanently visible

Coding - required elements

Raw ingredients

Records of process establishment

Scheduled process - scientific methods not used

Scheduled processes not established

Thermal processing - timing devices

Evaluation by process authority

No corrective action taken

Process deviation log/file

Entry not timely

Record form not signed

Recording device records - dated; retort number

Review not timely

Incomplete information

Insufficient frequency of management review

Not signed by closure inspector

Distribution record

Inspected site

Inspection team

Cited regulations

Source document

Form 483 source document

Get the verbatim text of all 33 observations