Custom RX LLC, dba Custom RX Compounding Pharmacy
Form 483 issued August 28, 2014 · Richfield, Minnesota
- Inspection
- Aug 11 – Aug 28, 2014
- Investigator
- April L. Young
- Observations
- 9
- Pages
- 4
- FEI number
- 3003316042
In short: On August 28, 2014, FDA issued a Form 483 with 9 observations to Custom RX LLC, dba Custom RX Compounding Pharmacy in Richfield, Minnesota (FEI 3003316042) after an inspection that ran Aug 11 – Aug 28, 2014. The investigator was April L. Young. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The operations relating to the manufacture, processing, and packing ofpenicillin are not performed in facilities separate…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 03
In-process materials are not tested for identity, strength, quality, and purity and approved or rejected by…
- 04
In-process specifications are not consistent with…
This inspection in context
April L. Young
5 documents · 2014–2015
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Minnesota.
The firmCustom RX LLC, dba Custom RX Compounding Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom RX LLC, dba Custom RX Compounding Pharmacy?
FDA listed 9 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Custom RX LLC, dba Custom RX Compounding Pharmacy?
April L. Young is named on this Form 483, for the inspection of Aug 11 – Aug 28, 2014. Each investigator has a profile showing what they cite most.
When was Custom RX LLC, dba Custom RX Compounding Pharmacy inspected by FDA?
The inspection ran Aug 11 – Aug 28, 2014, and the Form 483 is dated August 28, 2014.
How do I get the full Form 483 for Custom RX LLC, dba Custom RX 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.