Sharp Packaging Services, LLC
Form 483 issued April 24, 2019 · Allentown, Pennsylvania
- Inspection
- Apr 23 – Apr 24, 2019
- Investigator
- Craig D. Zagata
- Observations
- 1
- Pages
- 1
- FEI number
- 3004161147
In short: On April 24, 2019, FDA issued a Form 483 with 1 observation to Sharp Packaging Services, LLC in Allentown, Pennsylvania (FEI 3004161147) after an inspection that ran Apr 23 – Apr 24, 2019. The investigator was Craig D. Zagata. Most observations concern materials; the most-cited regulation is 21 CFR 211.184 (component, drug product container, closure, and labeling records).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.184(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The component records do not include the results of tests or examinations performed and the conclusions…
This inspection in context
Craig D. Zagata
11 documents · 2016–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmSharp Packaging Services, 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 211.184(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Packaging Services, LLC?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.184 (component, drug product container, closure, and labeling records). The opening words of each observation are shown on this page.
Who inspected Sharp Packaging Services, LLC?
Craig D. Zagata is named on this Form 483, for the inspection of Apr 23 – Apr 24, 2019. Each investigator has a profile showing what they cite most.
When was Sharp Packaging Services, LLC inspected by FDA?
The inspection ran Apr 23 – Apr 24, 2019, and the Form 483 is dated April 24, 2019.
How do I get the full Form 483 for Sharp Packaging Services, 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.