PureTek Corporation
Form 483 issued October 24, 2024 · PANORAMA CITY, California
- Inspection
- Oct 21 – Oct 24, 2024
- Investigator
- Khoa Nathan V. Tran
- Observations
- 2
- Pages
- 4
- FEI number
- 3012818008
In short: On October 24, 2024, FDA issued a Form 483 with 2 observations to PureTek Corporation in PANORAMA CITY, California (FEI 3012818008) after an inspection that ran Oct 21 – Oct 24, 2024. The investigator was Khoa Nathan V. Tran. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(a) (1×) · 211.67(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
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 firmPureTek Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PureTek Corporation?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected PureTek Corporation?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Oct 21 – Oct 24, 2024. Each investigator has a profile showing what they cite most.
When was PureTek Corporation inspected by FDA?
The inspection ran Oct 21 – Oct 24, 2024, and the Form 483 is dated October 24, 2024.
How do I get the full Form 483 for PureTek 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.