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Form 483

Hi-Tech Pharmacal, an AKORN Company Form 483, 2013-10-30

FDA issued a Form 483 to Hi-Tech Pharmacal, an AKORN Company on 2013-10-30 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Hi-Tech Pharmacal, an AKORN Company · Amityville, United States · Issued October 30, 2013

Overview

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

Inspectional observations

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

30 Oct 2013
21 CFR 211.160(b)(3)

Drug products-sampling procedures/specifications

Cited by Robert C Steyert

Inspected site

HPHi-Tech Pharmacal, an AKORN CompanyAmityville, United States

Inspection team

RCRobert C Steyert

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

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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