Atlas

Form 483

Time-Cap Laboratories, Inc. Form 483, 2013-03-18

FDA issued a Form 483 to Time-Cap Laboratories, Inc. on 2013-03-18 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Time-Cap Laboratories, Inc. · Farmingdale, United States · Issued March 18, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

18 Mar 2013
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Charisse K Green

18 Mar 2013
21 CFR 211.166(a)

Written program not followed

Cited by Charisse K Green

Inspected site

TLTime-Cap Laboratories, Inc.Farmingdale, United States

Inspection team

CKCharisse K Green

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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