Bora Pharmaceutical Laboratories Inc.
Form 483 issued February 7, 2020 · Taoyuan City, Taiwan
- Observations
- 2
- Pages
- 2
- FEI number
- 3005674517
In short: On February 7, 2020, FDA issued a Form 483 with 2 observations to Bora Pharmaceutical Laboratories Inc. in Taoyuan City, Taiwan (FEI 3005674517). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Questions about this 483
What did FDA find at Bora Pharmaceutical Laboratories Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Bora Pharmaceutical Laboratories Inc. inspected by FDA?
This Form 483 is dated February 7, 2020.
How do I get the full Form 483 for Bora Pharmaceutical Laboratories Inc.?
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.