Taiwan Biotech Co, Ltd
Form 483 issued September 11, 2017 · Taoyuan City, Taiwan
- Inspection
- Sep 1 – Sep 11, 2017
- Observations
- 4
- Pages
- 4
- FEI number
- 3003598505
In short: On September 11, 2017, FDA issued a Form 483 with 4 observations to Taiwan Biotech Co, Ltd in Taoyuan City, Taiwan (FEI 3003598505) after an inspection that ran Sep 1 – Sep 11, 2017. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
The written stability testing program is…
- 03
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Taiwan Biotech Co, Ltd?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
When was Taiwan Biotech Co, Ltd inspected by FDA?
The inspection ran Sep 1 – Sep 11, 2017, and the Form 483 is dated September 11, 2017.
How do I get the full Form 483 for Taiwan Biotech Co, Ltd?
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.