People's Custom Rx and Clinical Care, LLC
Form 483 issued August 5, 2021 · Memphis, Tennessee
- Inspection
- Jul 13 – Aug 5, 2021
- Investigators
- Clinton J. Lott· Marvin D. Jones
- Observations
- 3
- Pages
- 3
- FEI number
- 3003780900
In short: On August 5, 2021, FDA issued a Form 483 with 3 observations to People's Custom Rx and Clinical Care, LLC in Memphis, Tennessee (FEI 3003780900) after an inspection that ran Jul 13 – Aug 5, 2021. The investigators were Clinton J. Lott and Marvin D. Jones. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 02
Pressure differentials between areas with different air classifications were not monitored prior or…
- 03
Non-microbial contamination was observed in your…
This inspection in context
Clinton J. Lott
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected People's Custom Rx and Clinical Care, LLC?
Clinton J. Lott and Marvin D. Jones are named on this Form 483, for the inspection of Jul 13 – Aug 5, 2021. 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 13 – Aug 5, 2021, and the Form 483 is dated August 5, 2021.
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.