Washington Homeopathic Products
Form 483 issued August 19, 2021 · Berkeley Springs, West Virginia
- Inspection
- Aug 5 – Aug 19, 2021
- Investigator
- Anastasia M. Shields
- Observations
- 3
- Pages
- 5
- FEI number
- 3006489197
In short: On August 19, 2021, 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 5 – Aug 19, 2021. The investigator was Anastasia M. Shields. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
The written stability testing…
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 3 observations on this Form 483, mostly about quality system, production and laboratory controls. 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 Aug 5 – Aug 19, 2021. Each investigator has a profile showing what they cite most.
When was Washington Homeopathic Products inspected by FDA?
The inspection ran Aug 5 – Aug 19, 2021, and the Form 483 is dated August 19, 2021.
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.