Sharp Packaging Services, LLC
Form 483 issued January 28, 2022 · Allentown, Pennsylvania
- Inspection
- Dec 20, 2021 – Jan 28, 2022
- Investigators
- Jessica S. Estriplet· Yvins Dezan
- Observations
- 13
- Pages
- 20
- FEI number
- 3004161147
In short: On January 28, 2022, FDA issued a Form 483 with 13 observations to Sharp Packaging Services, LLC in Allentown, Pennsylvania (FEI 3004161147) after an inspection that ran Dec 20, 2021 – Jan 28, 2022. The investigators were Jessica S. Estriplet and Yvins Dezan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The quality control unit lacks the responsibility and authority to approve all components…
- 03
Complaint records are deficient in that they do not include the findings of the…
- 04
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Packaging Services, LLC?
FDA listed 13 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Sharp Packaging Services, LLC?
Jessica S. Estriplet and Yvins Dezan are named on this Form 483, for the inspection of Dec 20, 2021 – Jan 28, 2022. Each investigator has a profile showing what they cite most.
When was Sharp Packaging Services, LLC inspected by FDA?
The inspection ran Dec 20, 2021 – Jan 28, 2022, and the Form 483 is dated January 28, 2022.
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.