ZIIP INC
Form 483 issued January 12, 2026 · Pleasant Hill, California
- Inspection
- Jan 5 – Jan 12, 2026
- Investigator
- Sara M. Onyango
- Observations
- 8
- Pages
- 9
- FEI number
- 3029740697
In short: On January 12, 2026, FDA issued a Form 483 with 8 observations to ZIIP INC in Pleasant Hill, California (FEI 3029740697) after an inspection that ran Jan 5 – Jan 12, 2026. The investigator was Sara M. Onyango. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 7 of 8 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
EUPLOVE,S) SGNATURE DATENSSUED Procedures for corrective and preventive action have…
- 03
Design verification does not confirm that design output…
- 04
Procedures for design validation have…
This inspection in context
Sara M. Onyango
9 documents · 2019–2026
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmZIIP INC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ZIIP INC?
FDA listed 8 observations on this Form 483, mostly about design controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected ZIIP INC?
Sara M. Onyango is named on this Form 483, for the inspection of Jan 5 – Jan 12, 2026. Each investigator has a profile showing what they cite most.
When was ZIIP INC inspected by FDA?
The inspection ran Jan 5 – Jan 12, 2026, and the Form 483 is dated January 12, 2026.
How do I get the full Form 483 for ZIIP 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.