SV Labs Corporation
Form 483 issued October 23, 2025 · Watsonville, California
- Inspection
- Oct 20 – Oct 23, 2025
- Investigator
- Nathan E. Hellman
- Observations
- 5
- Pages
- 5
- FEI number
- 2936586
In short: On October 23, 2025, FDA issued a Form 483 with 5 observations to SV Labs Corporation in Watsonville, California (FEI 2936586) after an inspection that ran Oct 20 – Oct 23, 2025. The investigator was Nathan E. Hellman. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
The batch production and control records do not include a statement of the actual yield and…
This inspection in context
Nathan E. Hellman
6 documents · 2025–2026
Cites 211.84(a) (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmSV Labs Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SV Labs Corporation?
FDA listed 5 observations on this Form 483, mostly about materials, facilities & equipment and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected SV Labs Corporation?
Nathan E. Hellman is named on this Form 483, for the inspection of Oct 20 – Oct 23, 2025. Each investigator has a profile showing what they cite most.
When was SV Labs Corporation inspected by FDA?
The inspection ran Oct 20 – Oct 23, 2025, and the Form 483 is dated October 23, 2025.
How do I get the full Form 483 for SV Labs Corporation?
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.