Atlas

FDA-Inspected Site

Zenni Optical, Inc.

2 FDA inspections are on record for Zenni Optical, Inc. in Novato, United States.

Clean· No action indicated

Novato, United States · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2015-12-15.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Dec 2015Medical Devices & Rad HealthClean
29 Jan 2009Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

29 Jan 2009
21 CFR 820.20

Management responsibility

Cited by Quynh Strandberg, James C Yee, Jennifer H Rhyu, Mabel M Lee, Aaron G Pang

29 Jan 2009
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Quynh Strandberg, James C Yee, Jennifer H Rhyu, Mabel M Lee, Aaron G Pang

29 Jan 2009
21 CFR 820.20(c)

Management review - Lack of or inadequate procedures

Cited by Quynh Strandberg, James C Yee, Jennifer H Rhyu, Mabel M Lee, Aaron G Pang

29 Jan 2009
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Quynh Strandberg, James C Yee, Jennifer H Rhyu, Mabel M Lee, Aaron G Pang

29 Jan 2009
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Quynh Strandberg, James C Yee, Jennifer H Rhyu, Mabel M Lee, Aaron G Pang

Investigators

FDA investigators tied to this site in the record.

Maida Henesian1 insp.
Quynh Strandberg1 insp.
James C Yee1 insp.
Jennifer H Rhyu1 insp.
Mabel M Lee1 insp.
Aaron G Pang1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.160(a)Cited across public-safe Form 483 observations1x
21 CFR 820.180Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.20Cited across public-safe Form 483 observations1x
21 CFR 820.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Zenni Optical, Inc.'s 1 Form 483

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat