Washington Homeopathic Products
Form 483 issued August 23, 2023 · Berkeley Springs, West Virginia
- Inspection
- Aug 10 – Aug 23, 2023
- Investigators
- Jonah S. Ufferfilge· Yaharn Su
- Observations
- 3
- Pages
- 5
- FEI number
- 3006489197
In short: On August 23, 2023, FDA issued a Form 483 with 3 observations to Washington Homeopathic Products in Berkeley Springs, West Virginia (FEI 3006489197) after an inspection that ran Aug 10 – Aug 23, 2023. The investigators were Jonah S. Ufferfilge and Yaharn Su. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
2 of 3 observations on this 483 concern materials.
What FDA observed
Preview: the opening words of each observation- 01
Failure to reject any lot of drug product containers and closures that did not meet the…
- 02
The quality control unit lacks authority to fully investigate…
- 03
Containers are not opened and sampled in a manner designed to prevent…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmWashington Homeopathic Products history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Washington Homeopathic Products?
FDA listed 3 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Washington Homeopathic Products?
Jonah S. Ufferfilge and Yaharn Su are named on this Form 483, for the inspection of Aug 10 – Aug 23, 2023. Each investigator has a profile showing what they cite most.
When was Washington Homeopathic Products inspected by FDA?
The inspection ran Aug 10 – Aug 23, 2023, and the Form 483 is dated August 23, 2023.
How do I get the full Form 483 for Washington Homeopathic Products?
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.