ChiRhoClin, Inc
Form 483 issued November 3, 2022 · Burtonsville, Maryland
- Inspection
- Oct 31 – Nov 3, 2022
- Investigators
- Marcellinus D. Dordunoo· Natasha Gupta· Pushpa S. Jayasekara
- Observations
- 6
- Pages
- 6
- FEI number
- 3003194366
In short: On November 3, 2022, FDA issued a Form 483 with 6 observations to ChiRhoClin, Inc in Burtonsville, Maryland (FEI 3003194366) after an inspection that ran Oct 31 – Nov 3, 2022. The investigators were Marcellinus D. Dordunoo, Natasha Gupta and Pushpa S. Jayasekara. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 02
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
The quality control unit lacks authority to review production records to assure that no errors have…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmChiRhoClin, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ChiRhoClin, Inc?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. 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.
Who inspected ChiRhoClin, Inc?
Marcellinus D. Dordunoo, Natasha Gupta and Pushpa S. Jayasekara are named on this Form 483, for the inspection of Oct 31 – Nov 3, 2022. Each investigator has a profile showing what they cite most.
When was ChiRhoClin, Inc inspected by FDA?
The inspection ran Oct 31 – Nov 3, 2022, and the Form 483 is dated November 3, 2022.
How do I get the full Form 483 for ChiRhoClin, Inc?
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.