Sharp Sterile Manufacturing, LLC
Form 483 issued June 12, 2024 · Lee, Massachusetts
- Inspection
- Jun 4 – Jun 12, 2024
- Investigators
- Brentley Collins· Latorie S. Jones
- Observations
- 4
- Pages
- 5
- FEI number
- 3012144557
In short: On June 12, 2024, FDA issued a Form 483 with 4 observations to Sharp Sterile Manufacturing, LLC in Lee, Massachusetts (FEI 3012144557) after an inspection that ran Jun 4 – Jun 12, 2024. The investigators were Brentley Collins and Latorie S. Jones. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) 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 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Sterile Manufacturing, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Sharp Sterile Manufacturing, LLC?
Brentley Collins and Latorie S. Jones are named on this Form 483, for the inspection of Jun 4 – Jun 12, 2024. Each investigator has a profile showing what they cite most.
When was Sharp Sterile Manufacturing, LLC inspected by FDA?
The inspection ran Jun 4 – Jun 12, 2024, and the Form 483 is dated June 12, 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.