Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant
Form 483 issued November 4, 2022 · Taoyuan, Taiwan
- Inspection
- Nov 4, 2022
- Observations
- 3
- Pages
- 3
- FEI number
- 3015505405
In short: On November 4, 2022, FDA issued a Form 483 with 3 observations to Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant in Taoyuan, Taiwan (FEI 3015505405) after an inspection that ran Nov 4, 2022. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Questions about this 483
What did FDA find at Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
When was Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant inspected by FDA?
The inspection ran Nov 4, 2022, and the Form 483 is dated November 4, 2022.
How do I get the full Form 483 for Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.