Chemisphere Corporation
Form 483 issued March 17, 2020 · Saint Louis, Missouri
- Inspection
- Mar 16 – Mar 17, 2020
- Observations
- 2
- Pages
- 2
- FEI number
- 1000158477
In short: On March 17, 2020, FDA issued a Form 483 with 2 observations to Chemisphere Corporation in Saint Louis, Missouri (FEI 1000158477) after an inspection that ran Mar 16 – Mar 17, 2020. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Complaint records are deficient in that they do not document, the reason and the individual making…
This inspection in context
Questions about this 483
What did FDA find at Chemisphere Corporation?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Chemisphere Corporation inspected by FDA?
The inspection ran Mar 16 – Mar 17, 2020, and the Form 483 is dated March 17, 2020.
How do I get the full Form 483 for Chemisphere Corporation?
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.