Sharp Sterile Manufacturing, LLC
Form 483 issued January 20, 2023 · Lee, Massachusetts
- Inspection
- Jan 16, 2023
- Investigators
- Carl Perez· Jie He· Obinna Echcozo
- Observations
- 6
- Pages
- 3
- FEI number
- 3012144557
In short: On January 20, 2023, FDA issued a Form 483 with 6 observations to Sharp Sterile Manufacturing, LLC in Lee, Massachusetts (FEI 3012144557) after an inspection that ran Jan 16, 2023. The investigators were Carl Perez, Jie He and Obinna Echcozo. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.100 (2×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Cleaning procedures are not…
- 04
Adequate contamination control during the manufacture of drug product is…
This inspection in context
Carl Perez
7 documents · 2022–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmSharp Sterile Manufacturing, LLC history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Sterile Manufacturing, LLC?
FDA listed 6 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Sharp Sterile Manufacturing, LLC?
Carl Perez, Jie He and Obinna Echcozo are named on this Form 483, for the inspection of Jan 16, 2023. Each investigator has a profile showing what they cite most.
When was Sharp Sterile Manufacturing, LLC inspected by FDA?
The inspection ran Jan 16, 2023, and the Form 483 is dated January 20, 2023.
How do I get the full Form 483 for Sharp Sterile Manufacturing, 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.