Small Beginnings, Inc
Form 483 issued June 23, 2021 · Hesperia, California
- Inspection
- Jun 22 – Jun 23, 2021
- Investigator
- Juan Wu
- Observations
- 2
- Pages
- 2
- FEI number
- 3003469115
In short: On June 23, 2021, FDA issued a Form 483 with 2 observations to Small Beginnings, Inc in Hesperia, California (FEI 3003469115) after an inspection that ran Jun 22 – Jun 23, 2021. The investigator was Juan Wu. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
CAPA and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.90(a) (1×) · 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
- 02
Procedures for quality audits have…
This inspection in context
Juan Wu
1 document · 2021
Cites 820.22 (quality audit) more than any other section. Most of their documents are for sites in California.
The firmSmall Beginnings, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Small Beginnings, Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA and management controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Small Beginnings, Inc?
Juan Wu is named on this Form 483, for the inspection of Jun 22 – Jun 23, 2021. Each investigator has a profile showing what they cite most.
When was Small Beginnings, Inc inspected by FDA?
The inspection ran Jun 22 – Jun 23, 2021, and the Form 483 is dated June 23, 2021.
How do I get the full Form 483 for Small Beginnings, 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.