FEI 3021769057
FDA inspection history across 2 sites, 2022 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2022: one Form 483; 2023: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s and one warning letter, at Cypress, California and San Francisco, California.
- 2022The longest 483 on file: 4 observations over 8 pages at Cypress, California.
Cited most
Across all site observations on file
- 21 CFR 820.198Complaint files2
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.250Statistical techniques1
- 21 CFR 820.75(a)Process validation1
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
Cypress, California
Two Form 483s · 2022 to 2024 · 7 observations
Latest: Form 483, Jul 31, 2024 →San Francisco, California
One warning letter · 2023
Latest: Warning letter, May 25, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-31 | 483 Form 483 | Cypress, California | 3 | $99 |
| 2023-05-25 | Warning letter Warning letter | San Francisco, California | — | $99 |
| 2022-08-12 | 483 Form 483 | Cypress, California | 4 | $99 |
Investigators on these documents
Alexandria L. Capuano (1)James R. Montero (1)Janet Pulver (1)Katlin N. Stubbs (1)
FEI number 3021769057 · most recent document Jul 31, 2024
About FEI 3021769057
How many FDA Form 483s has FEI 3021769057 received?
FDA Intel has 2 Form 483s on file for FEI 3021769057; the most recent is dated Jul 31, 2024.
When was FEI 3021769057 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3021769057 is a Form 483 dated Jul 31, 2024, for the site in Cypress, California.
What did FDA cite at FEI 3021769057?
The regulations cited most in the observations on file for FEI 3021769057 are 21 CFR 820.198 (Complaint files), 2 times; 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has FEI 3021769057 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3021769057; the most recent is dated May 25, 2023.