Bausch Health Americas, Inc.
Form 483 issued April 12, 2024 · Petaluma, California
- Inspection
- Apr 8 – Apr 12, 2024
- Observations
- 1
- Pages
- 3
- FEI number
- 1000135370
In short: On April 12, 2024, FDA issued a Form 483 with 1 observation to Bausch Health Americas, Inc. in Petaluma, California (FEI 1000135370) after an inspection that ran Apr 8 – Apr 12, 2024. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Questions about this 483
What did FDA find at Bausch Health Americas, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Bausch Health Americas, Inc. inspected by FDA?
The inspection ran Apr 8 – Apr 12, 2024, and the Form 483 is dated April 12, 2024.
How do I get the full Form 483 for Bausch Health Americas, 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.