Washington Homeopathic Products
Form 483 issued July 2, 2019 · Berkeley Springs, West Virginia
- Inspection
- Jun 18 – Jul 2, 2019
- Investigator
- Anastasia M. Shields
- Observations
- 6
- Pages
- 6
- FEI number
- 3006489197
In short: On July 2, 2019, FDA issued a Form 483 with 6 observations to Washington Homeopathic Products in Berkeley Springs, West Virginia (FEI 3006489197) after an inspection that ran Jun 18 – Jul 2, 2019. The investigator was Anastasia M. Shields. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is no written assessment of stability of homeopathic drug products based at least on testing…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
The identity of each component of a drug product is not verified by conducting at least…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Washington Homeopathic Products?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Washington Homeopathic Products?
Anastasia M. Shields is named on this Form 483, for the inspection of Jun 18 – Jul 2, 2019. Each investigator has a profile showing what they cite most.
When was Washington Homeopathic Products inspected by FDA?
The inspection ran Jun 18 – Jul 2, 2019, and the Form 483 is dated July 2, 2019.
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.