Complete Pharmacy & Medical Solutions, LLC
Form 483 issued January 23, 2019 · Miami Lakes, Florida
- Inspection
- Jan 9 – Jan 23, 2019
- Investigator
- Jennifer L. Huntington
- Observations
- 7
- Pages
- 5
- FEI number
- 3010922197
In short: On January 23, 2019, FDA issued a Form 483 with 7 observations to Complete Pharmacy & Medical Solutions, LLC in Miami Lakes, Florida (FEI 3010922197) after an inspection that ran Jan 9 – Jan 23, 2019. The investigator was Jennifer L. Huntington. Most observations concern packaging & labeling and quality system.
At a glance
Observations span 4 systems, led by packaging & labeling.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmComplete Pharmacy & Medical Solutions, 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Complete Pharmacy & Medical Solutions, LLC?
FDA listed 7 observations on this Form 483, mostly about packaging & labeling, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Complete Pharmacy & Medical Solutions, LLC?
Jennifer L. Huntington is named on this Form 483, for the inspection of Jan 9 – Jan 23, 2019. Each investigator has a profile showing what they cite most.
When was Complete Pharmacy & Medical Solutions, LLC inspected by FDA?
The inspection ran Jan 9 – Jan 23, 2019, and the Form 483 is dated January 23, 2019.
How do I get the full Form 483 for Complete Pharmacy & Medical Solutions, 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.