Prescription Labs, Inc. dba Greenpark Compounding Pharmacy

Form 483 issued October 27, 2017 · Houston, Texas

Inspection: Oct 16 – Oct 27, 2017
Investigator: Stephen D. Brown
Observations: 6
Pages: 2
FEI number: 3009712882

In short: On October 27, 2017, FDA issued a Form 483 with 6 observations to Prescription Labs, Inc. dba Greenpark Compounding Pharmacy in Houston, Texas (FEI 3009712882) after an inspection that ran Oct 16 – Oct 27, 2017. The investigator was Stephen D. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

5 of 6 observations on this 483 concern production.

Production5

Facilities & equipment1

Most cited: 21 CFR 211.113 (4×)

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 211.28
On 10/17/17, an operator engaged in aseptic processing was observed with his upper torso inside the…
02
21 CFR 211.113
On 10/17/17, an operator was observed sanitizing his gloved hands with non-sterile (b) (4) and then…
03
21 CFR 211.113
The wipes used for disinfecting the interior of the ISO 5…
04
21 CFR 211.46
The ISO 5 classified areas were not…

2 more observations

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

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This inspection in context

The investigator

Stephen D. Brown

42 documents · 2006–2021

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

The firm

Prescription Labs, Inc. dba Greenpark Compounding 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 483Nov 30, 2017$199

Prescription Labs, Inc. dba Greenpark Compounding Pharmacy site file

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Questions about this 483

What did FDA find at Prescription Labs, Inc. dba Greenpark Compounding Pharmacy?

FDA listed 6 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.

Who inspected Prescription Labs, Inc. dba Greenpark Compounding Pharmacy?

Stephen D. Brown is named on this Form 483, for the inspection of Oct 16 – Oct 27, 2017. Each investigator has a profile showing what they cite most.

When was Prescription Labs, Inc. dba Greenpark Compounding Pharmacy inspected by FDA?

The inspection ran Oct 16 – Oct 27, 2017, and the Form 483 is dated October 27, 2017.

How do I get the full Form 483 for Prescription Labs, Inc. dba Greenpark Compounding Pharmacy?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.