Promise Pharmacy, LLC
Form 483 issued September 23, 2021 · Palm Harbor, Florida
- Inspection
- Aug 30 – Sep 23, 2021
- Investigator
- Marvin D. Jones
- Observations
- 2
- Pages
- 4
- FEI number
- 3013207472
In short: On September 23, 2021, FDA issued a Form 483 with 2 observations to Promise Pharmacy, LLC in Palm Harbor, Florida (FEI 3013207472) after an inspection that ran Aug 30 – Sep 23, 2021. The investigator was Marvin D. Jones. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You used a non-pharmaceutical grade component in the formulation…
- 02
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Promise Pharmacy, LLC?
FDA listed 2 observations on this Form 483, mostly about production. 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 Promise Pharmacy, LLC?
Marvin D. Jones is named on this Form 483, for the inspection of Aug 30 – Sep 23, 2021. Each investigator has a profile showing what they cite most.
When was Promise Pharmacy, LLC inspected by FDA?
The inspection ran Aug 30 – Sep 23, 2021, and the Form 483 is dated September 23, 2021.
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.