Sharp Sterile Manufacturing, LLC
Form 483 issued August 25, 2023 · Lee, Massachusetts
- Inspection
- Aug 14 – Aug 25, 2023
- Investigator
- Jonathan G. Matrisciano
- Observations
- 1
- Pages
- 2
- FEI number
- 3012144557
In short: On August 25, 2023, FDA issued a Form 483 with 1 observation to Sharp Sterile Manufacturing, LLC in Lee, Massachusetts (FEI 3012144557) after an inspection that ran Aug 14 – Aug 25, 2023. The investigator was Jonathan G. Matrisciano. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 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
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sharp Sterile Manufacturing, LLC?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Aug 14 – Aug 25, 2023. Each investigator has a profile showing what they cite most.
When was Sharp Sterile Manufacturing, LLC inspected by FDA?
The inspection ran Aug 14 – Aug 25, 2023, and the Form 483 is dated August 25, 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.