Atlas

Form 483

Hi-Tech Pharmaceuticals, Inc. Form 483, 2023-01-27

FDA issued a Form 483 to Hi-Tech Pharmaceuticals, Inc. on 2023-01-27 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Hi-Tech Pharmaceuticals, Inc. · Norcross, United States · Issued January 27, 2023

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

27 Jan 2023
21 CFR 111.155(e)

Components - contamination, deterioration, mix-ups

Cited by Janet B Gray, Sandra R Saunders

27 Jan 2023
21 CFR 111.20(b)

Physical plant - space; equipment, materials

Cited by Janet B Gray, Sandra R Saunders

27 Jan 2023
21 CFR 111.453

Written procedures - holding

Cited by Janet B Gray, Sandra R Saunders

Inspected site

HPHi-Tech Pharmaceuticals, Inc.Norcross, United States

Inspection team

JBJanet B Gray
SRSandra R Saunders

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.155(e)Cited across public-safe Form 483 observations1x
21 CFR 111.20(b)Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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