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Form 483

Re Growth Llc Form 483, 2011-03-07

FDA issued a Form 483 to Re Growth Llc on 2011-03-07 with 4 public-safe observations.

483· Form 483 issued4 observations

Re Growth Llc · Whittier, United States · Issued March 7, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

7 Mar 2011
21 CFR 211.130

Procedures are written, and followed

Cited by Albert C Cheng, Andy B Lee

7 Mar 2011
21 CFR 211.137(a)

Expiration date lacking

Cited by Albert C Cheng, Andy B Lee

7 Mar 2011
21 CFR 211.150

Written distribution procedure

Cited by Albert C Cheng, Andy B Lee

7 Mar 2011
21 CFR 211.150(b)

Recall facilitation

Cited by Albert C Cheng, Andy B Lee

Inspected site

RGRe Growth LlcWhittier, United States

Inspection team

ACAlbert C Cheng
ABAndy B Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.130Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.150Cited across public-safe Form 483 observations1x
21 CFR 211.150(b)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 4 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