Atlas

Form 483

DPT Laboratories, Ltd. Form 483, 2018-12-14

FDA issued a Form 483 to DPT Laboratories, Ltd. on 2018-12-14 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

DPT Laboratories, Ltd. · San Antonio, United States · Issued December 14, 2018

Overview

  • 6 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.

14 Dec 2018
21 CFR 211.182

Written records kept in individual logs

Cited by Santos E Camara

14 Dec 2018
21 CFR 211.188(b)(2)

Identification of Equipment and Lines

Cited by Santos E Camara

14 Dec 2018
21 CFR 211.22(a)

Authority lacking to review records, investigate errors

Cited by Santos E Camara

14 Dec 2018
21 CFR 211.182

Written records kept in individual logs

Cited by Santos E Camara

14 Dec 2018
21 CFR 211.188(b)(2)

Identification of Equipment and Lines

Cited by Santos E Camara

Inspected site

DLDPT Laboratories, Ltd.San Antonio, United States

Inspection team

SESantos E Camara

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.182Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.22(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 observations

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