Arkema, Inc.
Form 483 issued September 22, 2021 · Piffard, New York
- Inspection
- Sep 20 – Sep 22, 2021
- Observations
- 3
- Pages
- 3
- FEI number
- 1314624
In short: On September 22, 2021, FDA issued a Form 483 with 3 observations to Arkema, Inc. in Piffard, New York (FEI 1314624) after an inspection that ran Sep 20 – Sep 22, 2021. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The cleaning validation of all API products…
- 02
The procedures for the annual quality standards record evaluation are deficient in that they do not…
- 03
The responsibilities and procedures applicable to the quality control unit are not…
This inspection in context
Questions about this 483
What did FDA find at Arkema, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was Arkema, Inc. inspected by FDA?
The inspection ran Sep 20 – Sep 22, 2021, and the Form 483 is dated September 22, 2021.
How do I get the full Form 483 for Arkema, 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.