Zyno Medical LLC
FDA inspection history in Natick, Massachusetts, 2016 to 2023
- 2
- Warning letters
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Form 483
- Warning letter
- Close-out
2016: one warning letter; 2018: one close-out letter; 2022: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18One warning letter and one close-out letter, at Natick, Massachusetts.
- 2022–23One warning letter and one Form 483, at Natick, Massachusetts.
Cited most
Across all Zyno Medical observations on file
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(c)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
The complete Zyno Medical file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Natick, Massachusetts
Two warning letters, two close-out letters and one Form 483 · 2016 to 2023 · 4 observations
Latest: Form 483, Aug 16, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-16 | 483 Form 483 | Natick, Massachusetts | 4 | $99 |
| 2022-07-12 | Warning letter Warning letter | Natick, Massachusetts | — | $99 |
| 2018-12-03 | Close-out Close-out letter | Natick, Massachusetts | — | $99 |
| 2016-12-05 | Warning letter Warning letter | Natick, Massachusetts | — | $99 |
| Undated | Close-out Close-out letter | Natick, Massachusetts | — | $99 |
Investigators on these documents
FEI number 3006575795 · most recent document Aug 16, 2023
About Zyno Medical LLC
How many FDA Form 483s has Zyno Medical LLC received?
FDA Intel has 1 Form 483 on file for Zyno Medical LLC; the most recent is dated Aug 16, 2023.
When was Zyno Medical LLC last inspected by FDA?
The most recent FDA inspection document on file for Zyno Medical LLC is a Form 483 dated Aug 16, 2023, for the site in Natick, Massachusetts.
What did FDA cite at Zyno Medical LLC?
The regulations cited most in the observations on file for Zyno Medical LLC are 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time.
Has Zyno Medical LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Zyno Medical LLC; the most recent is dated Jul 12, 2022.