Silgan Unicep Packaging Lie
Form 483 issued June 14, 2024 · Spokane, Washington
- Inspection
- Jun 10 – Jun 14, 2024
- Investigators
- Andrew Le· Khoa Nathan V. Tran· Navneet Kaur
- Observations
- 5
- Pages
- 5
- FEI number
- 3011913386
In short: On June 14, 2024, FDA issued a Form 483 with 5 observations to Silgan Unicep Packaging Lie in Spokane, Washington (FEI 3011913386) after an inspection that ran Jun 10 – Jun 14, 2024. The investigators were Andrew Le, Khoa Nathan V. Tran and Navneet Kaur. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
3 of 5 observations on this 483 concern materials.
Most cited: 21 CFR 211.84(d)(2) (3×)
What FDA observed
Preview: the opening words of each observation- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Andrew Le
10 documents · 2022–2025
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmSilgan Unicep Packaging Lie 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(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Silgan Unicep Packaging Lie?
FDA listed 5 observations on this Form 483, mostly about materials, laboratory controls and facilities & equipment. 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 Silgan Unicep Packaging Lie?
Andrew Le, Khoa Nathan V. Tran and Navneet Kaur are named on this Form 483, for the inspection of Jun 10 – Jun 14, 2024. Each investigator has a profile showing what they cite most.
When was Silgan Unicep Packaging Lie inspected by FDA?
The inspection ran Jun 10 – Jun 14, 2024, and the Form 483 is dated June 14, 2024.
How do I get the full Form 483 for Silgan Unicep Packaging Lie?
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.