C-Care LLC
Form 483 issued February 27, 2025 · Linthicum Heights, Maryland
- Investigator
- Azeezat M. Lawal
- Observations
- 1
- Pages
- 3
- FEI number
- 3003071856
In short: On February 27, 2025, FDA issued a Form 483 with 1 observation to C-Care LLC in Linthicum Heights, Maryland (FEI 3003071856). The investigator was Azeezat M. Lawal. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Azeezat M. Lawal
8 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C-Care LLC?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected C-Care LLC?
Azeezat M. Lawal is named on this Form 483. Each investigator has a profile showing what they cite most.
When was C-Care LLC inspected by FDA?
This Form 483 is dated February 27, 2025.
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.