Sharp Sterile Manufacturing, LLC
Form 483 issued October 21, 2024 · Lee, Massachusetts
- Inspection
- Oct 14 – Oct 21, 2024
- Investigator
- Andrea Franco
- Observations
- 8
- Pages
- 7
- FEI number
- 3012144557
In short: On October 21, 2024, FDA issued a Form 483 with 8 observations to Sharp Sterile Manufacturing, LLC in Lee, Massachusetts (FEI 3012144557) after an inspection that ran Oct 14 – Oct 21, 2024. The investigator was Andrea Franco. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.113 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbial contamination of drug products purporting to be sterile are not…
- 02
The (b) (4) formulation process is not adequately controlled or designed to minimize the contamination risk…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
The program for the visual inspection (VI) of sterile injectable drug products does not provide adequate…
This inspection in context
Andrea Franco
5 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Sterile Manufacturing, LLC?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Sharp Sterile Manufacturing, LLC?
Andrea Franco is named on this Form 483, for the inspection of Oct 14 – Oct 21, 2024. Each investigator has a profile showing what they cite most.
When was Sharp Sterile Manufacturing, LLC inspected by FDA?
The inspection ran Oct 14 – Oct 21, 2024, and the Form 483 is dated October 21, 2024.
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.