The Ritedose Corporation
Form 483 issued March 18, 2022 · Columbia, South Carolina
- Inspection
- Mar 7 – Mar 18, 2022
- Investigator
- Jared P. Stevens
- Observations
- 1
- Pages
- 2
- FEI number
- 3001237796
In short: On March 18, 2022, FDA issued a Form 483 with 1 observation to The Ritedose Corporation in Columbia, South Carolina (FEI 3001237796) after an inspection that ran Mar 7 – Mar 18, 2022. The investigator was Jared P. Stevens. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in South Carolina.
The firmThe Ritedose Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Ritedose Corporation?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected The Ritedose Corporation?
Jared P. Stevens is named on this Form 483, for the inspection of Mar 7 – Mar 18, 2022. Each investigator has a profile showing what they cite most.
When was The Ritedose Corporation inspected by FDA?
The inspection ran Mar 7 – Mar 18, 2022, and the Form 483 is dated March 18, 2022.
How do I get the full Form 483 for The Ritedose 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.