People's Custom Rx and Clinical Care, LLC
Form 483 issued July 24, 2019 · Memphis, Tennessee
- Inspection
- Jul 16 – Jul 24, 2019
- Investigator
- Stephen D. Brown
- Observations
- 4
- Pages
- 2
- FEI number
- 3003780900
In short: On July 24, 2019, FDA issued a Form 483 with 4 observations to People's Custom Rx and Clinical Care, LLC in Memphis, Tennessee (FEI 3003780900) after an inspection that ran Jul 16 – Jul 24, 2019. 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
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel did not disinfect…
- 02
The cleaning wipes used in the lSO 5 classified aseptic processing…
- 03
Review of the certification report for the cleanrooms dated 3/28/19 revealed that smoke studies in the…
- 04
Your firm produced highly potent drugs without providing adequate cleaning of work…
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 4 observations on this Form 483, mostly about production and facilities & equipment. 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 Jul 16 – Jul 24, 2019. 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 16 – Jul 24, 2019, and the Form 483 is dated July 24, 2019.
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.