Absolute Pharmacy, LLC
Form 483 issued April 11, 2016 · Lutz, Florida
- Inspection
- Mar 24, 2016
- Investigator
- Jessica L. Pressley
- Observations
- 9
- Pages
- 8
- FEI number
- 3011116100
In short: On April 11, 2016, FDA issued a Form 483 with 9 observations to Absolute Pharmacy, LLC in Lutz, Florida (FEI 3011116100) after an inspection that ran Mar 24, 2016. The investigator was Jessica L. Pressley. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions; cleaning and disinfecting the…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
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 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Absolute Pharmacy, LLC?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Absolute Pharmacy, LLC?
Jessica L. Pressley is named on this Form 483, for the inspection of Mar 24, 2016. Each investigator has a profile showing what they cite most.
When was Absolute Pharmacy, LLC inspected by FDA?
The inspection ran Mar 24, 2016, and the Form 483 is dated April 11, 2016.
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.