Form 483

Health Plus Incorporated Form 483, 2015-02-17

FDA issued a Form 483 to Health Plus Incorporated on 2015-02-17 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

Health Plus Incorporated · Chino, United States · Issued February 17, 2015

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

17 Feb 2015
21 CFR 111.10(b)

Personnel - hygienic practices

Cited by Michael D Garcia

17 Feb 2015
21 CFR 111.10(b)(7)

Personal belongings

Cited by Michael D Garcia

17 Feb 2015
21 CFR 111.315

Laboratory control processes - reviewed, approved

Cited by Michael D Garcia

17 Feb 2015
21 CFR 211.166(a)

Lack of written stability program

Cited by Michael D Garcia

17 Feb 2015
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Michael D Garcia

Inspected site

HPHealth Plus IncorporatedChino, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.10(b)Cited across public-safe Form 483 observations1x
21 CFR 111.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 111.315Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 5 observations

The source PDF and 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