Coastal Meds, LLC
FDA inspection history in Biloxi, Mississippi, 2014 to 2018
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one Form 483; 2015: one Form 483; 2016: one warning letter; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–18Three Form 483s and one warning letter, at Biloxi, Mississippi.
- 2018The longest 483 on file: 11 observations over 7 pages at Biloxi, Mississippi.
Cited most
Across all Coastal Meds observations on file
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.137Expiration dating3
- 21 CFR 211.192Production record review3
- 21 CFR 211.28Personnel responsibilities2
The complete Coastal Meds file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Biloxi, Mississippi
Three Form 483s and one warning letter · 2014 to 2018 · 30 observations
Latest: Form 483, Apr 6, 2018 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-04-06 | 483 Form 483 | Biloxi, Mississippi | 11 | $99 |
| 2016-06-22 | Warning letter Warning letter | Biloxi, Mississippi | — | $99 |
| 2015-09-23 | 483 Form 483 | Biloxi, Mississippi | 10 | $99 |
| 2014-11-10 | 483 Form 483 | Biloxi, Mississippi | 9 | $99 |
Investigators on these documents
Claire M. Minden (1)Marvin D. Jones (1)Samantha J. Bradley (1)
FEI number 3005180755 · most recent document Apr 6, 2018
About Coastal Meds, LLC
How many FDA Form 483s has Coastal Meds, LLC received?
FDA Intel has 3 Form 483s on file for Coastal Meds, LLC; the most recent is dated Apr 6, 2018.
When was Coastal Meds, LLC last inspected by FDA?
The most recent FDA inspection document on file for Coastal Meds, LLC is a Form 483 dated Apr 6, 2018, for the site in Biloxi, Mississippi.
What did FDA cite at Coastal Meds, LLC?
The regulations cited most in the observations on file for Coastal Meds, LLC are 21 CFR 211.42 (Design and construction features), 7 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.137 (Expiration dating), 3 times.
Has Coastal Meds, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Coastal Meds, LLC; the most recent is dated Jun 22, 2016.