Form 483

Quong Hop & Co Form 483, 2010-05-04

FDA issued a Form 483 to Quong Hop & Co on 2010-05-04 with 10 public-safe observations.

483· Form 483 issued10 observations

Quong Hop & Co · South San Francisco, United States · Issued May 4, 2010

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

4 May 2010
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski

4 May 2010
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski

4 May 2010
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski

4 May 2010
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski

4 May 2010
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Cindy W Lewis, Mabel M Lee, Brett W Podoski

Inspected site

QHQuong Hop & CoSouth San Francisco, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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