LCC Ltd.
Form 483 issued March 22, 2024
- Inspection
- Mar 18 – Mar 22, 2024
- Investigator
- Brittny C. Cargo
- Observations
- 11
- Pages
- 11
- FEI number
- 3007255059
In short: On March 22, 2024, FDA issued a Form 483 with 11 observations to LCC Ltd. (FEI 3007255059) after an inspection that ran Mar 18 – Mar 22, 2024. The investigator was Brittny C. Cargo. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Each component is not tested for conformity with all appropriate written specifications for…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Records associated with drug product components, production, control and distribution and within the retention period for…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
The firmLCC Ltd. history
All 3 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 LCC Ltd.?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected LCC Ltd.?
Brittny C. Cargo is named on this Form 483, for the inspection of Mar 18 – Mar 22, 2024. Each investigator has a profile showing what they cite most.
When was LCC Ltd. inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2024, and the Form 483 is dated March 22, 2024.
How do I get the full Form 483 for LCC Ltd.?
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.