Bond Pharmacy Inc. dba Advanced Infusion Solutions

Form 483 issued October 27, 2015 · Ridgeland, Mississippi

Inspection: Sep 15 – Oct 27, 2015
Investigators: June P. Page· Marvin D. Jones
Observations: 5
Pages: 5
FEI number: 3011804748

In short: On October 27, 2015, FDA issued a Form 483 with 5 observations to Bond Pharmacy Inc. dba Advanced Infusion Solutions in Ridgeland, Mississippi (FEI 3011804748) after an inspection that ran Sep 15 – Oct 27, 2015. The investigators were June P. Page and Marvin D. Jones. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

3 of 5 observations on this 483 concern facilities & equipment.

Facilities & equipment3

Laboratory controls1

Production1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system…
02
21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
03
21 CFR 211.42(c)(10)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
04
21 CFR 211.167(a)
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…

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

June P. Page

30 documents · 2015–2025

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

The firm

Bond Pharmacy Inc. dba Advanced Infusion Solutions history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42(c)(10)(iv)

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Nov 16, 2015$199

Bond Pharmacy Inc. dba Advanced Infusion Solutions site file

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Questions about this 483

What did FDA find at Bond Pharmacy Inc. dba Advanced Infusion Solutions?

FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Bond Pharmacy Inc. dba Advanced Infusion Solutions?

June P. Page and Marvin D. Jones are named on this Form 483, for the inspection of Sep 15 – Oct 27, 2015. Each investigator has a profile showing what they cite most.

When was Bond Pharmacy Inc. dba Advanced Infusion Solutions inspected by FDA?

The inspection ran Sep 15 – Oct 27, 2015, and the Form 483 is dated October 27, 2015.

How do I get the full Form 483 for Bond Pharmacy Inc. dba Advanced Infusion Solutions?

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