Pontis Orthopaedics, LLC
FDA inspection history in San Francisco, California, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at San Francisco, California.
Cited most
Across all Pontis Orthopaedics observations on file
- 21 CFR 820.100(b)Corrective and preventive action1
- 21 CFR 820.180General requirements1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.30(g)Design controls1
The complete Pontis Orthopaedics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
San Francisco, California
One Form 483 · 2018 · 8 observations
Latest: Form 483, Jul 5, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-07-05 | 483 Form 483 | San Francisco, California | 8 | $99 |
Investigators on these documents
FEI number 3010034074 · most recent document Jul 5, 2018
About Pontis Orthopaedics, LLC
How many FDA Form 483s has Pontis Orthopaedics, LLC received?
FDA Intel has 1 Form 483 on file for Pontis Orthopaedics, LLC; the most recent is dated Jul 5, 2018.
When was Pontis Orthopaedics, LLC last inspected by FDA?
The most recent FDA inspection document on file for Pontis Orthopaedics, LLC is a Form 483 dated Jul 5, 2018, for the site in San Francisco, California.
What did FDA cite at Pontis Orthopaedics, LLC?
The regulations cited most in the observations on file for Pontis Orthopaedics, LLC are 21 CFR 820.100(b) (Corrective and preventive action), 1 time; 21 CFR 820.180 (General requirements), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time.