Boehringer Ingelheim Animal Health do Brasil Ltda
Form 483 issued December 13, 2022 · Paulínia, Brazil
- Inspection
- Dec 5 – Dec 13, 2022
- Observations
- 4
- Pages
- 6
- FEI number
- 3002764224
In short: On December 13, 2022, FDA issued a Form 483 with 4 observations to Boehringer Ingelheim Animal Health do Brasil Ltda in Paulínia, SP (FEI 3002764224) after an inspection that ran Dec 5 – Dec 13, 2022. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Questions about this 483
What did FDA find at Boehringer Ingelheim Animal Health do Brasil Ltda?
FDA listed 4 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
When was Boehringer Ingelheim Animal Health do Brasil Ltda inspected by FDA?
The inspection ran Dec 5 – Dec 13, 2022, and the Form 483 is dated December 13, 2022.
How do I get the full Form 483 for Boehringer Ingelheim Animal Health do Brasil Ltda?
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.