Colonia Care Pharmacy

Form 483 issued April 15, 2016 · Colonia, New Jersey

Inspection: Mar 3 – Apr 15, 2016
Investigator: Nicholas Violand
Observations: 5
Pages: 4
FEI number: 3012223534

In short: On April 15, 2016, FDA issued a Form 483 with 5 observations to Colonia Care Pharmacy in Colonia, New Jersey (FEI 3012223534) after an inspection that ran Mar 3 – Apr 15, 2016. The investigator was Nicholas Violand. Most observations concern laboratory controls and facilities & equipment.

At a glance

Laboratory controls and facilities & equipment account for 3 of 5 observations.

Laboratory controls2

Facilities & equipment1

Production1

Materials1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.166(a)
There is no written testing program designed to assess the stability…
02
21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
03
21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system…
04
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to·be sterile do not 'include validation…

1 more observation

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

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This inspection in context

The investigator

Nicholas Violand

17 documents · 2013–2022

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.

The firm

Colonia Care Pharmacy 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 211.166(a)

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483May 5, 2016$199

Colonia Care Pharmacy site file

All 6 documents for this site in one go: $675 instead of ~~$794~~, 15% off.

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Questions about this 483

What did FDA find at Colonia Care Pharmacy?

FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.

Who inspected Colonia Care Pharmacy?

Nicholas Violand is named on this Form 483, for the inspection of Mar 3 – Apr 15, 2016. Each investigator has a profile showing what they cite most.

When was Colonia Care Pharmacy inspected by FDA?

The inspection ran Mar 3 – Apr 15, 2016, and the Form 483 is dated April 15, 2016.

How do I get the full Form 483 for Colonia Care Pharmacy?

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