Promise Pharmacy, LLC
Form 483 issued October 25, 2018 · Palm Harbor, Florida
- Inspection
- Oct 25, 2018
- Investigator
- Jennifer L. Huntington
- Observations
- 8
- Pages
- 6
- FEI number
- 3013207472
In short: On October 25, 2018, FDA issued a Form 483 with 8 observations to Promise Pharmacy, LLC in Palm Harbor, Florida (FEI 3013207472) after an inspection that ran Oct 25, 2018. The investigator was Jennifer L. Huntington. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drng products purporting to…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 03
The flow of components, dtug product containers, closmes and in-process materials though the building is not…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
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 firmPromise Pharmacy, LLC history
All 3 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 Promise Pharmacy, LLC?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. 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 Promise Pharmacy, LLC?
Jennifer L. Huntington is named on this Form 483, for the inspection of Oct 25, 2018. Each investigator has a profile showing what they cite most.
When was Promise Pharmacy, LLC inspected by FDA?
The inspection ran Oct 25, 2018, and the Form 483 is dated October 25, 2018.
How do I get the full Form 483 for Promise 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.