Health and Natural Beauty USA Corp
Form 483 issued October 15, 2024 · Piscataway, New Jersey
- Inspection
- Oct 9 – Oct 15, 2024
- Investigator
- James R. Birkenstamm
- Observations
- 4
- Pages
- 4
- FEI number
- 3011061274
In short: On October 15, 2024, FDA issued a Form 483 with 4 observations to Health and Natural Beauty USA Corp in Piscataway, New Jersey (FEI 3011061274) after an inspection that ran Oct 9 – Oct 15, 2024. The investigator was James R. Birkenstamm. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
James R. Birkenstamm
12 documents · 2018–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmHealth and Natural Beauty USA Corp history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Health and Natural Beauty USA Corp?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Health and Natural Beauty USA Corp?
James R. Birkenstamm is named on this Form 483, for the inspection of Oct 9 – Oct 15, 2024. Each investigator has a profile showing what they cite most.
When was Health and Natural Beauty USA Corp inspected by FDA?
The inspection ran Oct 9 – Oct 15, 2024, and the Form 483 is dated October 15, 2024.
How do I get the full Form 483 for Health and Natural Beauty USA Corp?
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.