People's Custom Rx and Clinical Care, LLC
Form 483 issued July 29, 2015 · Memphis, Tennessee
- Inspection
- Jul 20 – Jul 29, 2015
- Investigators
- Mary A. Millner· Zada L. Giles
- Observations
- 9
- Pages
- 5
- FEI number
- 3003780900
In short: On July 29, 2015, FDA issued a Form 483 with 9 observations to People's Custom Rx and Clinical Care, LLC in Memphis, Tennessee (FEI 3003780900) after an inspection that ran Jul 20 – Jul 29, 2015. The investigators were Mary A. Millner and Zada L. Giles. 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 7 of 9 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
The flow of components, drug product containers, closures, in-process materials, and drug products though the building…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Mary A. Millner
9 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Tennessee.
The firmPeople's Custom Rx and Clinical Care, LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at People's Custom Rx and Clinical Care, LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 People's Custom Rx and Clinical Care, LLC?
Mary A. Millner and Zada L. Giles are named on this Form 483, for the inspection of Jul 20 – Jul 29, 2015. Each investigator has a profile showing what they cite most.
When was People's Custom Rx and Clinical Care, LLC inspected by FDA?
The inspection ran Jul 20 – Jul 29, 2015, and the Form 483 is dated July 29, 2015.
How do I get the full Form 483 for People's Custom Rx and Clinical Care, LLC?
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.