Surgitech Inc
FDA inspection history in Carlsbad, California, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Carlsbad, California.
Cited most
Across all Surgitech observations on file
- 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 820.100(a)Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
The complete Surgitech file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Carlsbad, California
One Form 483 · 2023 · 10 observations
Latest: Form 483, Aug 10, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-10 | 483 Form 483 | Carlsbad, California | 10 | $99 |
Investigators on these documents
FEI number 3004014634 · most recent document Aug 10, 2023
About Surgitech Inc
How many FDA Form 483s has Surgitech Inc received?
FDA Intel has 1 Form 483 on file for Surgitech Inc; the most recent is dated Aug 10, 2023.
When was Surgitech Inc last inspected by FDA?
The most recent FDA inspection document on file for Surgitech Inc is a Form 483 dated Aug 10, 2023, for the site in Carlsbad, California.
What did FDA cite at Surgitech Inc?
The regulations cited most in the observations on file for Surgitech Inc are 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 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.184 (Device history record), 1 time.