Atlas

Form 483

HOYA Corporation PENTAX Miyagi Factory Form 483, 2013-11-21

FDA issued a Form 483 to HOYA Corporation PENTAX Miyagi Factory on 2013-11-21 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

HOYA Corporation PENTAX Miyagi Factory · Kurihara, Japan · Issued November 21, 2013

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.

21 Nov 2013
21 CFR 820.40

Lack of procedures, or not maintained

Cited by Amy M Cramer

21 Nov 2013
21 CFR 820.70(e)

Contamination control, Lack of or inadequate procedures

Cited by Amy M Cramer

Inspected site

HCHOYA Corporation PENTAX Miyagi FactoryKurihara, Japan

Inspection team

AMAmy M Cramer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.70(e)Cited across public-safe Form 483 observations1x

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