Coastal Meds, LLC
Form 483 issued April 6, 2018 · Biloxi, Mississippi
- Inspection
- Mar 12 – Apr 6, 2018
- Investigator
- Samantha J. Bradley
- Observations
- 11
- Pages
- 7
- FEI number
- 3005180755
In short: On April 6, 2018, FDA issued a Form 483 with 11 observations to Coastal Meds, LLC in Biloxi, Mississippi (FEI 3005180755) after an inspection that ran Mar 12 – Apr 6, 2018. The investigator was Samantha J. Bradley. 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.
Most cited: 21 CFR 211.42 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Protective apparel is not worn as necessary to protect…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Samantha J. Bradley
14 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Coastal Meds, LLC?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and packaging & labeling. 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?
Samantha J. Bradley is named on this Form 483, for the inspection of Mar 12 – Apr 6, 2018. Each investigator has a profile showing what they cite most.
When was Coastal Meds, LLC inspected by FDA?
The inspection ran Mar 12 – Apr 6, 2018, and the Form 483 is dated April 6, 2018.
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.