C-Care LLC
Form 483 issued September 16, 2019 · Linthicum Heights, Maryland
- Inspection
- Sep 9 – Sep 16, 2019
- Investigators
- Jaison J. Eapen· Qin Xu
- Observations
- 6
- Pages
- 6
- FEI number
- 3003071856
In short: On September 16, 2019, FDA issued a Form 483 with 6 observations to C-Care LLC in Linthicum Heights, Maryland (FEI 3003071856) after an inspection that ran Sep 9 – Sep 16, 2019. The investigators were Jaison J. Eapen and Qin Xu. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 03
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 04
The quality control unit lacks the responsibility and authority to approve and reject all in process…
This inspection in context
Jaison J. Eapen
3 documents · 2019–2020
Cites 211.182 (equipment cleaning and use log) more than any other section. Most of their documents are for sites in Maryland.
The firmC-Care LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C-Care LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The opening words of each observation are shown on this page.
Who inspected C-Care LLC?
Jaison J. Eapen and Qin Xu are named on this Form 483, for the inspection of Sep 9 – Sep 16, 2019. Each investigator has a profile showing what they cite most.
When was C-Care LLC inspected by FDA?
The inspection ran Sep 9 – Sep 16, 2019, and the Form 483 is dated September 16, 2019.
How do I get the full Form 483 for C-Care LLC?
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.