Ziptek LLC
FDA inspection history in Sarasota, Florida, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Sarasota, Florida.
Cited most
Across all Ziptek observations on file
- 21 CFR 803.12(a)How do I submit initial and supplemental or followup reports?1
- 21 CFR 803.17(a)(3)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.20How do I complete and submit an individual adverse event report?1
- 21 CFR 820.25(b)Personnel1
- 21 CFR 820.40Document controls1
The complete Ziptek file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Sarasota, Florida
One Form 483 · 2024 · 3 observations
Latest: Form 483, May 22, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-22 | 483 Form 483 | Sarasota, Florida | 3 | $99 |
Investigators on these documents
FEI number 3013722959 · most recent document May 22, 2024
About Ziptek LLC
How many FDA Form 483s has Ziptek LLC received?
FDA Intel has 1 Form 483 on file for Ziptek LLC; the most recent is dated May 22, 2024.
When was Ziptek LLC last inspected by FDA?
The most recent FDA inspection document on file for Ziptek LLC is a Form 483 dated May 22, 2024, for the site in Sarasota, Florida.
What did FDA cite at Ziptek LLC?
The regulations cited most in the observations on file for Ziptek LLC are 21 CFR 803.12(a) (How do I submit initial and supplemental or followup reports?), 1 time; 21 CFR 803.17(a)(3) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.20 (How do I complete and submit an individual adverse event report?), 1 time.