Jost Chemical Co.
Form 483 issued October 13, 2023 · Saint Louis, Missouri
- Observations
- 2
- Pages
- 3
- FEI number
- 3001239108
In short: On October 13, 2023, FDA issued a Form 483 with 2 observations to Jost Chemical Co. in Saint Louis, Missouri (FEI 3001239108). Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations are not established and followed for investigating critical deviations or the failure…
- 02
Equipment is not designed and or cleaned at appropriate intervals to prevent ingress, build-up and…
This inspection in context
Questions about this 483
What did FDA find at Jost Chemical Co.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Jost Chemical Co. inspected by FDA?
This Form 483 is dated October 13, 2023.
How do I get the full Form 483 for Jost Chemical Co.?
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.