Jones Drug Company Inc. dba Reed's Compounding Pharmacy
Form 483 issued September 29, 2015 · Tucson, Arizona
- Inspection
- Sep 22 – Sep 29, 2015
- Investigator
- Alan P. Kurtzberg
- Observations
- 15
- Pages
- 12
- FEI number
- 3005468616
In short: On September 29, 2015, FDA issued a Form 483 with 15 observations to Jones Drug Company Inc. dba Reed's Compounding Pharmacy in Tucson, Arizona (FEI 3005468616) after an inspection that ran Sep 22 – Sep 29, 2015. The investigator was Alan P. Kurtzberg. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 12 of 15 observations.
Most cited: 21 CFR 211.42 (5×) · 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmJones Drug Company Inc. dba Reed's Compounding Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jones Drug Company Inc. dba Reed's Compounding Pharmacy?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 Jones Drug Company Inc. dba Reed's Compounding Pharmacy?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Sep 22 – Sep 29, 2015. Each investigator has a profile showing what they cite most.
When was Jones Drug Company Inc. dba Reed's Compounding Pharmacy inspected by FDA?
The inspection ran Sep 22 – Sep 29, 2015, and the Form 483 is dated September 29, 2015.
How do I get the full Form 483 for Jones Drug Company Inc. dba Reed's Compounding Pharmacy?
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