SAB HERBALS AND NUTRACEUTICALS
Form 483 issued November 22, 2024 · Udham Singh Nagar, India
- Inspection
- Nov 18 – Nov 22, 2024
- Investigator
- Truong X. Nguyen
- Observations
- 3
- Pages
- 2
- FEI number
- 3012863613
In short: On November 22, 2024, FDA issued a Form 483 with 3 observations to SAB HERBALS AND NUTRACEUTICALS in Udham Singh Nagar, India (FEI 3012863613) after an inspection that ran Nov 18 – Nov 22, 2024. The investigator was Truong X. Nguyen. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmSAB HERBALS AND NUTRACEUTICALS history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SAB HERBALS AND NUTRACEUTICALS?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected SAB HERBALS AND NUTRACEUTICALS?
Truong X. Nguyen is named on this Form 483, for the inspection of Nov 18 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was SAB HERBALS AND NUTRACEUTICALS inspected by FDA?
The inspection ran Nov 18 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for SAB HERBALS AND NUTRACEUTICALS?
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