ChiRhoClin, Inc
FDA inspection history in Burtonsville, Maryland, 2004 to 2022
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2004: one warning letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter, at Burtonsville, Maryland.
- 2022One Form 483, at Burtonsville, Maryland.
Cited most
Across all ChiRhoClin observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.25(c)Personnel qualifications1
The complete ChiRhoClin file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Burtonsville, Maryland
One Form 483 and one warning letter · 2004 to 2022 · 6 observations
Latest: Form 483, Nov 3, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-03 | 483 Form 483 | Burtonsville, Maryland | 6 | $99 |
| 2004-04-28 | Warning letter Warning letter | Burtonsville, Maryland | — | $99 |
Investigators on these documents
Marcellinus D. Dordunoo (1)Natasha Gupta (1)Pushpa S. Jayasekara (1)
FEI number 3003194366 · most recent document Nov 3, 2022
About ChiRhoClin, Inc
How many FDA Form 483s has ChiRhoClin, Inc received?
FDA Intel has 1 Form 483 on file for ChiRhoClin, Inc; the most recent is dated Nov 3, 2022.
When was ChiRhoClin, Inc last inspected by FDA?
The most recent FDA inspection document on file for ChiRhoClin, Inc is a Form 483 dated Nov 3, 2022, for the site in Burtonsville, Maryland.
What did FDA cite at ChiRhoClin, Inc?
The regulations cited most in the observations on file for ChiRhoClin, Inc are 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.68(a) (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.160(b) (General requirements), 1 time.
Has ChiRhoClin, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for ChiRhoClin, Inc; the most recent is dated Apr 28, 2004.