Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant
FDA inspection history in Taoyuan, Taiwan, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Taoyuan, Taiwan.
Cited most
Across all Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
The complete Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Taoyuan, Taiwan
One Form 483 · 2022 · 3 observations
Latest: Form 483, Nov 4, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-04 | 483 Form 483 | Taoyuan, Taiwan | 3 | $99 |
FEI number 3015505405 · most recent document Nov 4, 2022
About Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant
How many FDA Form 483s has Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant received?
FDA Intel has 1 Form 483 on file for Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant; the most recent is dated Nov 4, 2022.
When was Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant last inspected by FDA?
The most recent FDA inspection document on file for Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant is a Form 483 dated Nov 4, 2022, for the site in Taoyuan, Taiwan.
What did FDA cite at Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant?
The regulations cited most in the observations on file for Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.