Colonia Care Pharmacy

Form 483 issued July 26, 2021 · Colonia, New Jersey

Inspection: Jun 9 – Jul 26, 2021
Investigators: Jessica S. Estriplet· Unnee Ranjan
Observations: 3
Pages: 4
FEI number: 3012223534

In short: On July 26, 2021, FDA issued a Form 483 with 3 observations to Colonia Care Pharmacy in Colonia, New Jersey (FEI 3012223534) after an inspection that ran Jun 9 – Jul 26, 2021. The investigators were Jessica S. Estriplet and Unnee Ranjan.

What FDA observed

Preview: the opening words of each observation

01
FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
02
FDCA 501(a)(2)(A)
The use of sporicidal agents in the ISO 5 classified aseptic processing area…
03
FDCA 501(a)(2)(A)
You produced highly potent diugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of…

The full 483

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This inspection in context

The investigator

Jessica S. Estriplet

18 documents · 2021–2026

Cites 211.22 (responsibilities of quality control unit) 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.

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Response
The firm's reply to this 483Aug 17, 2021$199

Colonia Care Pharmacy site file

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Questions about this 483

What did FDA find at Colonia Care Pharmacy?

FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.

Who inspected Colonia Care Pharmacy?

Jessica S. Estriplet and Unnee Ranjan are named on this Form 483, for the inspection of Jun 9 – Jul 26, 2021. Each investigator has a profile showing what they cite most.

When was Colonia Care Pharmacy inspected by FDA?

The inspection ran Jun 9 – Jul 26, 2021, and the Form 483 is dated July 26, 2021.

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

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