Carla J. Lundi
FDA investigator
Appears on 9 documents from 2009 to 2021, mostly at sites in California. Most often cites general requirements (21 CFR 211.160).
- 9
- Documents on file
- 5.3
- Observations per 483
- 2009
- First seen
- 2021
- Most recent
What they cite most
From 48 observations- 21 CFR 211.160General requirements9
- 21 CFR 211.192Production record review7
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.103Calculation of yield2
- 21 CFR 211.113(b)Control of microbiological contamination2
Activity by year
2009: 1, 2010: 1, 2012: 1, 2015: 4, 2021: 2
Where
California 8 · India 1
Often inspects with
Is Carla J. Lundi coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
9 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2021-10-12 | 483 Revance Therapeutics, IncOct 12, 2021 · Newark, California | Newark, California | 5 | |
| 2021-07-02 | 483 Revance Therapeutics, Inc.Jul 2, 2021 · Newark, California | Newark, California | 5 | |
| 2015-12-22 | 483 Universal Packaging SystemsDec 22, 2015 · Chino, California | Chino, California | 3 | |
| 2015-11-23 | 483 Discus Dental LLCNov 23, 2015 · Ontario, California | Ontario, California | 10 | |
| 2015-05-22 | 483 AmgenMay 22, 2015 · Thousand Oaks, California | Thousand Oaks, California | 3 | |
| 2015-03-17 | 483 GLAND PHARMA LIMITEDMar 17, 2015 · Hyderabad, India | Hyderabad, India | 2 | |
| 2012-04-24 | 483 Teva Parenteral Medicines, Inc.Apr 24, 2012 · Irvine, California | Irvine, California | 2 |
About this profile
What does Carla J. Lundi inspect?
Carla J. Lundi appears on 9 documents on file covering 8 sites, mostly in California.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.192 and 21 CFR 211.42.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Carla J. Lundi is dated Oct 12, 2021.