Oakworks Inc
Form 483 issued January 17, 2024 · New Freedom, Pennsylvania
- Inspection
- Dec 13, 2023 – Jan 17, 2024
- Investigator
- Nadia R. Barreda
- Observations
- 2
- Pages
- 7
- FEI number
- 1000121370
In short: On January 17, 2024, FDA issued a Form 483 with 2 observations to Oakworks Inc in New Freedom, Pennsylvania (FEI 1000121370) after an inspection that ran Dec 13, 2023 – Jan 17, 2024. The investigator was Nadia R. Barreda. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The design was not validated under actual…
This inspection in context
Nadia R. Barreda
1 document · 2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmOakworks Inc history
The site's inspection history, in date order.
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 Oakworks Inc?
FDA listed 2 observations on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Oakworks Inc?
Nadia R. Barreda is named on this Form 483, for the inspection of Dec 13, 2023 – Jan 17, 2024. Each investigator has a profile showing what they cite most.
When was Oakworks Inc inspected by FDA?
The inspection ran Dec 13, 2023 – Jan 17, 2024, and the Form 483 is dated January 17, 2024.
How do I get the full Form 483 for Oakworks 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.