Coastal Meds, LLC
Form 483 issued November 10, 2014 · Biloxi, Mississippi
- Inspection
- Oct 20 – Nov 10, 2014
- Investigator
- Marvin D. Jones
- Observations
- 9
- Pages
- 3
- FEI number
- 3005180755
In short: On November 10, 2014, FDA issued a Form 483 with 9 observations to Coastal Meds, LLC in Biloxi, Mississippi (FEI 3005180755) after an inspection that ran Oct 20 – Nov 10, 2014. The investigator was Marvin D. Jones. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
areas are deficient regarding the system…
- 02
to prevent microbiological contamination of drug products purporting to be sterile do…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
The firmCoastal Meds, LLC history
All 4 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 Coastal Meds, LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Coastal Meds, LLC?
Marvin D. Jones is named on this Form 483, for the inspection of Oct 20 – Nov 10, 2014. Each investigator has a profile showing what they cite most.
When was Coastal Meds, LLC inspected by FDA?
The inspection ran Oct 20 – Nov 10, 2014, and the Form 483 is dated November 10, 2014.
How do I get the full Form 483 for Coastal Meds, 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.