FEI 3011248248
FDA inspection history across 3 sites, 2019 to 2024
- 6
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2020: one Form 483; 2021: one Form 483; 2022: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–24Six Form 483s, at Iskander Puteri, Malaysia; Iskandar Puteri, Malaysia and Iskandar Puteri, Johor, Malaysia.
- 2019The longest 483 on file: 12 observations over 12 pages at Iskander Puteri, Malaysia.
Cited most
Across all site observations on file
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.192Production record review6
- 21 CFR 211.67Equipment cleaning and maintenance5
- 21 CFR 211.160General requirements3
- 21 CFR 211.22Responsibilities of quality control unit3
The complete site file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Iskandar Puteri, Malaysia
Three Form 483s · 2020 to 2023 · 17 observations
Latest: Form 483, Jul 20, 2023 →Iskander Puteri, Malaysia
Two Form 483s · 2019 to 2024 · 20 observations
Latest: Form 483, Sep 27, 2024 →Iskandar Puteri, Johor, Malaysia
One Form 483 · 2022 · 4 observations
Latest: Form 483, Aug 30, 2022 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-27 | 483 Form 483 | Iskander Puteri, Malaysia | 8 | $99 |
| 2023-07-20 | 483 Form 483 | Iskandar Puteri, Malaysia | 8 | $99 |
| 2022-08-30 | 483 Form 483 | Iskandar Puteri, Johor, Malaysia | 4 | $99 |
| 2021-09-24 | 483 Form 483 | Iskandar Puteri, Malaysia | 6 | $99 |
| 2020-02-21 | 483 Form 483 | Iskandar Puteri, Malaysia | 3 | $99 |
| 2019-07-05 | 483 Form 483 | Iskander Puteri, Malaysia | 12 | $99 |
Investigators on these documents
Anjali Shukla (1)Daniel J. Lahar (1)Eileen A. Liu (1)Hamet Toure (1)Jeffrey P. Raimondi (1)Katherine D. Adams (1)Linda F. Murphy (1)Maryam Tabatabaie (1)Paranthaman Senthamarai Kannan (1)Patty P. Kaewussdangkul (1)Richard Ledwidge (1)Rong Guo (1)
FEI number 3011248248 · most recent document Sep 27, 2024
About FEI 3011248248
How many FDA Form 483s has FEI 3011248248 received?
FDA Intel has 6 Form 483s on file for FEI 3011248248; the most recent is dated Sep 27, 2024.
When was FEI 3011248248 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3011248248 is a Form 483 dated Sep 27, 2024, for the site in Iskander Puteri, Malaysia.
What did FDA cite at FEI 3011248248?
The regulations cited most in the observations on file for FEI 3011248248 are 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 5 times.