People's Custom Rx and Clinical Care, LLC
Form 483 issued June 25, 2018 · Memphis, Tennessee
- Inspection
- Jun 25, 2018
- Investigator
- Stephen D. Brown
- Observations
- 5
- Pages
- 2
- FEI number
- 3003780900
In short: On June 25, 2018, FDA issued a Form 483 with 5 observations to People's Custom Rx and Clinical Care, LLC in Memphis, Tennessee (FEI 3003780900) after an inspection that ran Jun 25, 2018. 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
Production and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
You have no assurance that the endotoxin level of your intrathecal drug products are safe, since…
- 03
On 6/27/18, I observed that the magnahelic gauge monitoring differential pressure between the ISO 8 anteroom…
- 04
SOP# 3.300.303 entitled "Disinfectant Solution an (4) '(Effective date: 9/1117) does not identify the contact time…
This inspection in context
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 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
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 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 People's Custom Rx and Clinical Care, LLC?
Stephen D. Brown is named on this Form 483, for the inspection of Jun 25, 2018. 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 Jun 25, 2018, and the Form 483 is dated June 25, 2018.
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.