PureTek Corporation
Form 483 issued March 7, 2025 · San Fernando, California
- Inspection
- Mar 4 – Mar 7, 2025
- Investigators
- Christopher R. Czajka· Lena Nguyen
- Observations
- 2
- Pages
- 3
- FEI number
- 1000125324
In short: On March 7, 2025, FDA issued a Form 483 with 2 observations to PureTek Corporation in San Fernando, California (FEI 1000125324) after an inspection that ran Mar 4 – Mar 7, 2025. The investigators were Christopher R. Czajka and Lena Nguyen. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and packaging & labeling account for 2 of 2 observations.
Most cited: 21 CFR 211.25(a) (1×) · 211.122(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Employees are not given training in the particular operations they perform as part of their function…
- 02
Access to the storage area for labels and labeling materials is not…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmPureTek Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25(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 quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected PureTek Corporation?
Christopher R. Czajka and Lena Nguyen are named on this Form 483, for the inspection of Mar 4 – Mar 7, 2025. Each investigator has a profile showing what they cite most.
When was PureTek Corporation inspected by FDA?
The inspection ran Mar 4 – Mar 7, 2025, and the Form 483 is dated March 7, 2025.
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.