Forces of Nature, Inc.
Form 483 issued January 20, 2023 · Sonoma, California
- Investigator
- Nicholas L. Hunt
- Observations
- 8
- Pages
- 5
- FEI number
- 3003846743
In short: On January 20, 2023, FDA issued a Form 483 with 8 observations to Forces of Nature, Inc. in Sonoma, California (FEI 3003846743). The investigator was Nicholas L. Hunt. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Deviations from written production and process control procedures are…
- 03
Each components not tested for conformity with all appropriate written specifications for…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmForces of Nature, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Forces of Nature, Inc.?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Forces of Nature, Inc.?
Nicholas L. Hunt is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Forces of Nature, Inc. inspected by FDA?
This Form 483 is dated January 20, 2023.
How do I get the full Form 483 for Forces of Nature, Inc.?
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.