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Form 483

Hi-Tech Pharmacal, an AKORN Company Form 483, 2016-07-15

FDA issued a Form 483 to Hi-Tech Pharmacal, an AKORN Company on 2016-07-15 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Hi-Tech Pharmacal, an AKORN Company · Amityville, United States · Issued July 15, 2016

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 6 investigators are tied to this Form 483.

Inspectional observations

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

15 Jul 2016
21 CFR 211.111

Establishment of time limitations

Cited by Sony Mathews, Alice S Tsao, Mindy M Chou, Helen B Ricalde, Marie B Buen-Bigornia, Robert C Steyert

Inspected site

HPHi-Tech Pharmacal, an AKORN CompanyAmityville, United States

Inspection team

SMSony Mathews
ASAlice S Tsao
MMMindy M Chou
HBHelen B Ricalde
MBMarie B Buen-Bigornia
RCRobert C Steyert

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.111Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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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