Absolute Pharmacy, LLC
Form 483 issued November 19, 2014 · Lutz, Florida
- Inspection
- Oct 27 – Nov 19, 2014
- Investigator
- Michael H. Tollon
- Observations
- 12
- Pages
- 7
- FEI number
- 3011116100
In short: On November 19, 2014, FDA issued a Form 483 with 12 observations to Absolute Pharmacy, LLC in Lutz, Florida (FEI 3011116100) after an inspection that ran Oct 27 – Nov 19, 2014. The investigator was Michael H. Tollon. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 8 of 12 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not…
- 03
The separate or defmed areas and control systems necessary to prevent contamination…
- 04
Aseptic processing areas are deficient regarding the system for…
This inspection in context
Michael H. Tollon
12 documents · 2013–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmAbsolute Pharmacy, 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Absolute Pharmacy, LLC?
FDA listed 12 observations on this Form 483, mostly about production, facilities & equipment and materials. 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 Absolute Pharmacy, LLC?
Michael H. Tollon is named on this Form 483, for the inspection of Oct 27 – Nov 19, 2014. Each investigator has a profile showing what they cite most.
When was Absolute Pharmacy, LLC inspected by FDA?
The inspection ran Oct 27 – Nov 19, 2014, and the Form 483 is dated November 19, 2014.
How do I get the full Form 483 for Absolute Pharmacy, 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.