FEI 3012242764
FDA inspection history in La Jolla, California, 2016 to 2017
- 1
- Warning letter
- 1
- EIR
- 1
- Form 483
Every document, by year
- Warning letter
- EIR
- Form 483
2016: one inspection report and one Form 483; 2017: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One inspection report, one Form 483 and one warning letter, at La Jolla, California.
Cited most
Across all site observations on file
- 21 CFR 312.56(a)Review of ongoing investigations2
- 21 CFR 312.62(a)Investigator recordkeeping and record retention2
- 21 CFR 312.60General responsibilities of investigators1
- 21 CFR 312.66Assurance of IRB review1
- 21 CFR 50.25(c)Elements of informed consent1
The complete site file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
La Jolla, California
One warning letter, one inspection report and one Form 483 · 2016 to 2017 · 7 observations
Latest: Warning letter, Jan 5, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-01-05 | Warning letter Warning letter | La Jolla, California | — | $99 |
| 2016-08-25 | EIR EIR | La Jolla, California | — | $550 |
| 2016-08-01 | 483 Form 483 | La Jolla, California | 7 | $99 |
Investigators on these documents
FEI number 3012242764 · most recent document Jan 5, 2017
About FEI 3012242764
How many FDA Form 483s has FEI 3012242764 received?
FDA Intel has 1 Form 483 on file for FEI 3012242764; the most recent is dated Aug 1, 2016.
When was FEI 3012242764 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3012242764 is an establishment inspection report (EIR) dated Aug 25, 2016, for the site in La Jolla, California.
What did FDA cite at FEI 3012242764?
The regulations cited most in the observations on file for FEI 3012242764 are 21 CFR 312.56(a) (Review of ongoing investigations), 2 times; 21 CFR 312.62(a) (Investigator recordkeeping and record retention), 2 times; 21 CFR 312.60 (General responsibilities of investigators), 1 time.
Has FEI 3012242764 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3012242764; the most recent is dated Jan 5, 2017.