Complete Pharmacy & Medical Solutions, LLC
Form 483 issued January 18, 2017 · Miami Lakes, Florida
- Inspection
- Aug 4, 2020
- Investigator
- Jessica L. Pressley
- Observations
- 12
- Pages
- 6
- FEI number
- 3010922197
In short: On January 18, 2017, FDA issued a Form 483 with 12 observations to Complete Pharmacy & Medical Solutions, LLC in Miami Lakes, Florida (FEI 3010922197) after an inspection that ran Aug 4, 2020. The investigator was Jessica L. Pressley. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.165 (4×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm lacks an adequate control system to ensure all containers and closures such as glass…
- 02
Your firm lacks an adequate control system for the - sterilization of Testosterone cypionate injectable in…
- 03
Aseptic processing areas are deficient regarding the system for…
- 04
Your ISO 517/8 classified areas where sterile injectable drug products are produced are not adequately sanitized…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) 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 211.165
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 12 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Complete Pharmacy & Medical Solutions, LLC?
Jessica L. Pressley is named on this Form 483, for the inspection of Aug 4, 2020. Each investigator has a profile showing what they cite most.
When was Complete Pharmacy & Medical Solutions, LLC inspected by FDA?
The inspection ran Aug 4, 2020, and the Form 483 is dated January 18, 2017.
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.