Sircle Laboratories, L.L.C
Form 483 issued April 26, 2021 · Madison, Mississippi
- Inspection
- Apr 13 – Apr 26, 2021
- Investigator
- Marvin D. Jones
- Observations
- 5
- Pages
- 5
- FEI number
- 3011772828
In short: On April 26, 2021, FDA issued a Form 483 with 5 observations to Sircle Laboratories, L.L.C in Madison, Mississippi (FEI 3011772828) after an inspection that ran Apr 13 – Apr 26, 2021. The investigator was Marvin D. Jones. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
4 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed, packed and…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
There is a lack of written procedures describing in sufficient detail the examination of…
- 04
Procedures describing the handling of written and oral complaints related to ding products are…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
The firmSircle Laboratories, L.L.C history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sircle Laboratories, L.L.C?
FDA listed 5 observations on this Form 483, mostly about quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Sircle Laboratories, L.L.C?
Marvin D. Jones is named on this Form 483, for the inspection of Apr 13 – Apr 26, 2021. Each investigator has a profile showing what they cite most.
When was Sircle Laboratories, L.L.C inspected by FDA?
The inspection ran Apr 13 – Apr 26, 2021, and the Form 483 is dated April 26, 2021.
How do I get the full Form 483 for Sircle Laboratories, L.L.C?
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.