Jost Chemical Co.
Form 483 issued January 21, 2022 · Saint Louis, Missouri
- Inspection
- Jan 10 – Jan 21, 2022
- Observations
- 6
- Pages
- 8
- FEI number
- 3001239108
In short: On January 21, 2022, FDA issued a Form 483 with 6 observations to Jost Chemical Co. in Saint Louis, Missouri (FEI 3001239108) after an inspection that ran Jan 10 – Jan 21, 2022. 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 4 of 6 observations.
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
Quality related complaints are not always investigated and, if appropriate, corrective actions…
- 03
Equipment is not cleaned at appropriate intervals to build-up…
- 04
Computer systems used in production and quality control laboratories do not have sufficient controls to prevent…
This inspection in context
Questions about this 483
What did FDA find at Jost Chemical Co.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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?
The inspection ran Jan 10 – Jan 21, 2022, and the Form 483 is dated January 21, 2022.
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.