Element Materials Technology Oakland
Form 483 issued January 30, 2026 · Concord, California
- Inspection
- Jan 21 – Jan 30, 2026
- Investigators
- Anney Lin· Homero W. Aguilar· Jolanna A. Norton
- Observations
- 6
- Pages
- 9
- FEI number
- 3006616583
In short: On January 30, 2026, FDA issued a Form 483 with 6 observations to Element Materials Technology Oakland in Concord, California (FEI 3006616583) after an inspection that ran Jan 21 – Jan 30, 2026. The investigators were Anney Lin, Homero W. Aguilar, Jolanna A. Norton and Roger F. Zabinski. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic…
- 03
Written records of investigations into the failure of a batch or any of its components to…
- 04
Laboratory records do not include a record of all calculations performed in…
This inspection in context
Anney Lin
9 documents · 2023–2026
Cites 211.84 (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 firmElement Materials Technology Oakland history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Element Materials Technology Oakland?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Element Materials Technology Oakland?
Anney Lin, Homero W. Aguilar, Jolanna A. Norton and Roger F. Zabinski are named on this Form 483, for the inspection of Jan 21 – Jan 30, 2026. Each investigator has a profile showing what they cite most.
When was Element Materials Technology Oakland inspected by FDA?
The inspection ran Jan 21 – Jan 30, 2026, and the Form 483 is dated January 30, 2026.
How do I get the full Form 483 for Element Materials Technology Oakland?
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.