Sharp Sterile Manufacturing, LLC
Form 483 issued October 15, 2021 · Lee, Massachusetts
- Inspection
- Oct 4 – Oct 15, 2021
- Investigators
- Daniel L. Zheng· Mindy M. Chou
- Observations
- 6
- Pages
- 5
- FEI number
- 3012144557
In short: On October 15, 2021, FDA issued a Form 483 with 6 observations to Sharp Sterile Manufacturing, LLC in Lee, Massachusetts (FEI 3012144557) after an inspection that ran Oct 4 – Oct 15, 2021. The investigators were Daniel L. Zheng and Mindy M. Chou. Most observations concern materials and facilities & equipment.
At a glance
Materials and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product containers were not clean and sterilized and processed to remove pyrogenic properties to assure…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Certificates of testing of containers and closures are accepted in lieu of testing without establishing the…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
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 211.94(c)
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 materials, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Sharp Sterile Manufacturing, LLC?
Daniel L. Zheng and Mindy M. Chou are named on this Form 483, for the inspection of Oct 4 – Oct 15, 2021. Each investigator has a profile showing what they cite most.
When was Sharp Sterile Manufacturing, LLC inspected by FDA?
The inspection ran Oct 4 – Oct 15, 2021, and the Form 483 is dated October 15, 2021.
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.