Med Shop Total Care Inc.
Form 483 issued July 27, 2021 · L ongview, Texas
- Inspection
- Jul 7 – Jul 27, 2021
- Investigator
- Claire M. Minden
- Observations
- 7
- Pages
- 5
- FEI number
- 3002835459
In short: On July 27, 2021, FDA issued a Form 483 with 7 observations to Med Shop Total Care Inc. in L ongview, Texas (FEI 3002835459) after an inspection that ran Jul 7 – Jul 27, 2021. The investigator was Claire M. Minden. 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 6 of 7 observations.
Most cited: 21 CFR 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02
Your facility design allowed the influx of poor-quality air into…
- 03
Non-microbial contamination was observed…
- 04
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmMed Shop Total Care Inc. history
All 6 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 Med Shop Total Care Inc.?
FDA listed 7 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 Med Shop Total Care Inc.?
Claire M. Minden is named on this Form 483, for the inspection of Jul 7 – Jul 27, 2021. Each investigator has a profile showing what they cite most.
When was Med Shop Total Care Inc. inspected by FDA?
The inspection ran Jul 7 – Jul 27, 2021, and the Form 483 is dated July 27, 2021.
How do I get the full Form 483 for Med Shop Total Care Inc.?
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.