ZECO, LLC
Form 483 issued July 19, 2024 · Chattanooga, Tennessee
- Investigator
- Martrice A. Packer
- Observations
- 5
- Pages
- 3
- FEI number
- 3016843495
In short: On July 19, 2024, FDA issued a Form 483 with 5 observations to ZECO, LLC in Chattanooga, Tennessee (FEI 3016843495). The investigator was Martrice A. Packer. Most observations concern laboratory controls and materials.
At a glance
Laboratory controls and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 210
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Specific identification tests are not conducted on components that have been accepted based on the…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Martrice A. Packer
6 documents · 2022–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Alabama.
The firmZECO, LLC history
The site's inspection history, in date order.
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 ZECO, LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, materials and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected ZECO, LLC?
Martrice A. Packer is named on this Form 483. Each investigator has a profile showing what they cite most.
When was ZECO, LLC inspected by FDA?
This Form 483 is dated July 19, 2024.
How do I get the full Form 483 for ZECO, 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.