Infupharma LLCd.b.a. President Pharmacy

Form 483 issued September 27, 2011 · Hollywood, Florida

Inspection: Jul 22, 2011
Investigators: Ileana Barreto-Pettit· Ileana Irarreto-I'enn
Observations: 13
Pages: 10
FEI number: 3008058540

In short: On September 27, 2011, FDA issued a Form 483 with 13 observations to Infupharma LLCd.b.a. President Pharmacy in Hollywood, Florida (FEI 3008058540) after an inspection that ran Jul 22, 2011. The investigators were Ileana Barreto-Pettit and Ileana Irarreto-I'enn. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).

At a glance

Observations span 4 systems, led by production.

Production3

Laboratory controls3

Quality system2

Facilities & equipment2

Other3

Most cited: 21 CFR 211.113 (2×) · 211.165 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
02
21 CFR 211.113
There are no written procedures for production and process controls designed to assure that the drug…
03
21 CFR 211.25
Employees are not trained and qualified on proper garbing practices and aseptic techniques prior to…
04
21 CFR 211.165
Each batch of drug product required to be free of objectionable microorganisms is not tested…

9 more observations

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

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This inspection in context

The investigator

Ileana Barreto-Pettit

25 documents · 2001–2022

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.

The firm

Infupharma LLCd.b.a. President Pharmacy history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Oct 10, 2011$199

Infupharma LLCd.b.a. President Pharmacy site file

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Questions about this 483

What did FDA find at Infupharma LLCd.b.a. President Pharmacy?

FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.

Who inspected Infupharma LLCd.b.a. President Pharmacy?

Ileana Barreto-Pettit and Ileana Irarreto-I'enn are named on this Form 483, for the inspection of Jul 22, 2011. Each investigator has a profile showing what they cite most.

When was Infupharma LLCd.b.a. President Pharmacy inspected by FDA?

The inspection ran Jul 22, 2011, and the Form 483 is dated September 27, 2011.

How do I get the full Form 483 for Infupharma LLCd.b.a. President Pharmacy?

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