Ziptek LLC
Form 483 issued May 22, 2024 · Sarasota, Florida
- Inspection
- May 20 – May 22, 2024
- Investigator
- Ulysses D. Singleton
- Observations
- 3
- Pages
- 3
- FEI number
- 3013722959
In short: On May 22, 2024, FDA issued a Form 483 with 3 observations to Ziptek LLC in Sarasota, Florida (FEI 3013722959) after an inspection that ran May 20 – May 22, 2024. The investigator was Ulysses D. Singleton. Most observations concern records & documents and management controls.
At a glance
Records & documents and management controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Document control procedures have…
- 02
Procedures for training and identifying training needs…
- 03
The written MDR procedme does not include an internal system which provides for timely transmission of…
This inspection in context
Ulysses D. Singleton
2 documents · 2024–2026
Cites 820 more than any other section. Most of their documents are for sites in Florida.
The firmZiptek LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.40
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ziptek LLC?
FDA listed 3 observations on this Form 483, mostly about records & documents, management controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Ziptek LLC?
Ulysses D. Singleton is named on this Form 483, for the inspection of May 20 – May 22, 2024. Each investigator has a profile showing what they cite most.
When was Ziptek LLC inspected by FDA?
The inspection ran May 20 – May 22, 2024, and the Form 483 is dated May 22, 2024.
How do I get the full Form 483 for Ziptek LLC?
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.