Coastal Meds, LLC
Form 483 issued September 23, 2015 · Biloxi, Mississippi
- Inspection
- Sep 15 – Sep 23, 2015
- Investigator
- Claire M. Minden
- Observations
- 10
- Pages
- 5
- FEI number
- 3005180755
In short: On September 23, 2015, FDA issued a Form 483 with 10 observations to Coastal Meds, LLC in Biloxi, Mississippi (FEI 3005180755) after an inspection that ran Sep 15 – Sep 23, 2015. The investigator was Claire M. Minden. Most observations concern packaging & labeling and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by packaging & labeling.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
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 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 10 observations on this Form 483, mostly about packaging & labeling, facilities & equipment and production. 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?
Claire M. Minden is named on this Form 483, for the inspection of Sep 15 – Sep 23, 2015. Each investigator has a profile showing what they cite most.
When was Coastal Meds, LLC inspected by FDA?
The inspection ran Sep 15 – Sep 23, 2015, and the Form 483 is dated September 23, 2015.
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.