FDA Intel

Foundation Care LLC

Form 483 issued March 19, 2013 · Earth City, Missouri

Inspection
Mar 11 – Mar 19, 2013
Investigators
Anthony R. Bucks· Michele Perry Williams· Shirley J. Berryman
Observations
7
Pages
6
FEI number
3005364771

In short: On March 19, 2013, FDA issued a Form 483 with 7 observations to Foundation Care LLC in Earth City, Missouri (FEI 3005364771) after an inspection that ran Mar 11 – Mar 19, 2013. The investigators were Anthony R. Bucks, Michele Perry Williams and Shirley J. Berryman. Most observations concern production and laboratory controls.

At a glance

Observations span 4 systems, led by production.

Production2
Laboratory controls2
Facilities & equipment2
Materials1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…

  2. 02
    21 CFR 211.28(a)

    Clothing ofpersonnel engaged in the processing of drug products is not appropriate for…

  3. 03
    21 CFR 211.160(b)

    Laboratory controls do not include the establishment ofscientificaDy sound and appropriate designed to assure that drug…

  4. 04
    21 CFR 211.165(b)

    Each batch of drug product required to be free of objectionable microorganisms is not tested…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Anthony R. Bucks

4 documents · 2013

Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Missouri.

The firm

Foundation Care LLC history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Foundation Care LLC?

FDA listed 7 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.

Who inspected Foundation Care LLC?

Anthony R. Bucks, Michele Perry Williams and Shirley J. Berryman are named on this Form 483, for the inspection of Mar 11 – Mar 19, 2013. Each investigator has a profile showing what they cite most.

When was Foundation Care LLC inspected by FDA?

The inspection ran Mar 11 – Mar 19, 2013, and the Form 483 is dated March 19, 2013.

How do I get the full Form 483 for Foundation Care LLC?

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