FEI 3004575449
FDA inspection history in San Diego, California, 2015 to 2025
- 13
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2019: five Form 483s; 2021: one Form 483; 2023: three Form 483s; 2025: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–2513 Form 483s, at San Diego, California.
- 2019The longest 483 on file: 8 observations over 7 pages at San Diego, California.
Cited most
Across all site observations on file
- 21 CFR 211.113Control of microbiological contamination11
- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.160General requirements6
- 21 CFR 211.192Production record review6
- 21 CFR 211.42Design and construction features5
The complete site file.
All 13 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
San Diego, California
13 Form 483s · 2015 to 2025 · 50 observations
Latest: Form 483, May 9, 2025 →
Documents
13 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-09 | 483 Form 483 | San Diego, California | 6 | $99 |
| 2025-05-09 | 483 Form 483 | San Diego, California | 6 | $99 |
| 2023-09-20 | 483 Form 483 | San Diego, California | 3 | $99 |
| 2023-02-09 | 483 Form 483 | San Diego, California | 7 | $99 |
| 2023-01-16 | 483 Form 483 | San Diego, California | 3 | $99 |
| 2021-05-25 | 483 Form 483 | San Diego, California | 3 | $99 |
| 2019-12-20 | 483 Form 483 | San Diego, California | 3 | $99 |
| 2019-11-22 | 483 Form 483 | San Diego, California | 4 | $99 |
| 2019-08-07 | 483 Form 483 | San Diego, California | 2 | $99 |
| 2019-03-22 | 483 Form 483 | San Diego, California | — | $99 |
| 2019-02-07 | 483 Form 483 | San Diego, California | 8 | $99 |
| 2017-04-06 | 483 Form 483 | San Diego, California | 3 | $99 |
| 2015-05-18 | 483 Form 483 | San Diego, California | 2 | $99 |
Investigators on these documents
Michael T. Cyrus (3)Joey V. Quitania (3)Santiago Gallardo Johnson (3)Elvis Patel (2)Jeffrey P. Raimondi (2)Michael R. Shanks (2)Khoa Nathan V. Tran (1)Lata Mathew (1)Omotunde O. Osunsanmi (1)Scott D. McGrew (1)Virginia A. Carroll (1)Amir Alavi (1)
FEI number 3004575449 · most recent document May 9, 2025
About FEI 3004575449
How many FDA Form 483s has FEI 3004575449 received?
FDA Intel has 13 Form 483s on file for FEI 3004575449; the most recent is dated May 9, 2025.
When was FEI 3004575449 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3004575449 is a Form 483 dated May 9, 2025, for the site in San Diego, California.
What did FDA cite at FEI 3004575449?
The regulations cited most in the observations on file for FEI 3004575449 are 21 CFR 211.113 (Control of microbiological contamination), 11 times; 21 CFR 211.22 (Responsibilities of quality control unit), 7 times; 21 CFR 211.160 (General requirements), 6 times.