Med Shop Total Care Inc.
Form 483 issued November 1, 2018 · Longview, Texas
- Inspection
- Oct 15 – Nov 1, 2018
- Investigator
- Clairem Minden
- Observations
- 10
- Pages
- 6
- FEI number
- 3002835459
In short: On November 1, 2018, FDA issued a Form 483 with 10 observations to Med Shop Total Care Inc. in Longview, Texas (FEI 3002835459) after an inspection that ran Oct 15 – Nov 1, 2018. The investigator was Clairem Minden. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Production and facilities & equipment account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Each batch of drug product purporting to be pyrogen-free is not laboratory tested to determine…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Clairem Minden
1 document · 2018
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Texas.
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 211.42(c)(10)(iv)
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 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Med Shop Total Care Inc.?
Clairem Minden is named on this Form 483, for the inspection of Oct 15 – Nov 1, 2018. Each investigator has a profile showing what they cite most.
When was Med Shop Total Care Inc. inspected by FDA?
The inspection ran Oct 15 – Nov 1, 2018, and the Form 483 is dated November 1, 2018.
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.