Form 483

Precision Pharmacy Center, LLC Form 483, 2016-06-10

FDA issued a Form 483 to Precision Pharmacy Center, LLC on 2016-06-10 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Precision Pharmacy Center, LLC · Brea, United States · Issued June 10, 2016

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

10 Jun 2016
21 CFR 211.166(a)

Lack of written stability program

Cited by Djamila Harouaka

10 Jun 2016
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Djamila Harouaka

10 Jun 2016
21 CFR 211.167(a)

Sterility/pyrogen-free testing

Cited by Djamila Harouaka

Inspected site

PPPrecision Pharmacy Center, LLCBrea, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.167(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)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 3 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