Form 483

C-Care LLC Form 483, 2019-09-16

FDA issued a Form 483 to C-Care LLC on 2019-09-16 with 14 public-safe observations.

483· Form 483 issuedHuman Drugs14 observations

C-Care LLC · Linthicum Heights, United States · Issued September 16, 2019

Overview

  • 14 public-safe observations are available for this inspection.
  • 6 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.

16 Sep 2019
21 CFR 211.182

Written records kept in individual logs

Cited by Qin Xu, Jaison J Eapen

16 Sep 2019
21 CFR 211.182

Written records kept in individual logs

Cited by Qin Xu, Jaison J Eapen

16 Sep 2019
21 CFR 211.22(a)

Approve or reject components, products

Cited by Qin Xu, Jaison J Eapen

16 Sep 2019
21 CFR 211.22(a)

Approve or reject components, products

Cited by Qin Xu, Jaison J Eapen

16 Sep 2019
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Qin Xu, Jaison J Eapen

Inspected site

CLC-Care LLCLinthicum Heights, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(a)Cited across public-safe Form 483 observations4x
21 CFR 211.182Cited across public-safe Form 483 observations2x
21 CFR 211.56(a)Cited across public-safe Form 483 observations2x
21 CFR 211.58Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.84(b)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 14 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