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Form 483

Hi-Tech Pharmacal, an AKORN Company Form 483, 2015-07-20

FDA issued a Form 483 to Hi-Tech Pharmacal, an AKORN Company on 2015-07-20 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Hi-Tech Pharmacal, an AKORN Company · Amityville, United States · Issued July 20, 2015

Overview

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

Inspectional observations

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

20 Jul 2015
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Felix Maldonado, Robert C Steyert, Nariman Patenaude

20 Jul 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Felix Maldonado, Robert C Steyert, Nariman Patenaude

20 Jul 2015
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Felix Maldonado, Robert C Steyert, Nariman Patenaude

Inspected site

HPHi-Tech Pharmacal, an AKORN CompanyAmityville, United States

Inspection team

FMFelix Maldonado
RCRobert C Steyert
NPNariman Patenaude

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)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.

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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