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Form 483

PML NYC, LLC Form 483, 2015-07-10

FDA issued a Form 483 to PML NYC, LLC on 2015-07-10 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

PML NYC, LLC · Long Island City, United States · Issued July 10, 2015

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 Jul 2015
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Mindy M Chou

10 Jul 2015
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Mindy M Chou

10 Jul 2015
21 CFR 211.63

Equipment Design, Size and Location

Cited by Mindy M Chou

Inspected site

PNPML NYC, LLCLong Island City, United States

Inspection team

MMMindy M Chou

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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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