FEI 3004051616
FDA inspection history across 2 sites, 2019 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Pashamylaram, India.
- 2022–24Two Form 483s, at Sangareddy, India.
- 2022The longest 483 on file: 5 observations over 11 pages at Sangareddy, India.
Cited most
Across all site observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.188Batch production and control records1
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
Sangareddy, India
Two Form 483s · 2022 to 2024 · 7 observations
Latest: Form 483, Dec 17, 2024 →Pashamylaram, India
One Form 483 · 2019 · 4 observations
Latest: Form 483, Oct 28, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-17 | 483 Form 483 | Sangareddy, India | 2 | $99 |
| 2022-02-15 | 483 Form 483 | Sangareddy, India | 5 | $99 |
| 2019-10-28 | 483 Form 483 | Pashamylaram, India | 4 | $99 |
Investigators on these documents
FEI number 3004051616 · most recent document Dec 17, 2024
About FEI 3004051616
How many FDA Form 483s has FEI 3004051616 received?
FDA Intel has 3 Form 483s on file for FEI 3004051616; the most recent is dated Dec 17, 2024.
When was FEI 3004051616 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3004051616 is a Form 483 dated Dec 17, 2024, for the site in Sangareddy, India.
What did FDA cite at FEI 3004051616?
The regulations cited most in the observations on file for FEI 3004051616 are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.