Sharp Sterile Manufacturing, LLC
Form 483 issued October 27, 2020 · Lee, Massachusetts
- Inspection
- Aug 26 – Oct 27, 2020
- Investigator
- Sony Mathews
- Observations
- 6
- Pages
- 10
- FEI number
- 3012144557
In short: On October 27, 2020, FDA issued a Form 483 with 6 observations to Sharp Sterile Manufacturing, LLC in Lee, Massachusetts (FEI 3012144557) after an inspection that ran Aug 26 – Oct 27, 2020. The investigator was Sony Mathews. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Deviations from written production and process control…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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 211.22(d)
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, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Sharp Sterile Manufacturing, LLC?
Sony Mathews is named on this Form 483, for the inspection of Aug 26 – Oct 27, 2020. Each investigator has a profile showing what they cite most.
When was Sharp Sterile Manufacturing, LLC inspected by FDA?
The inspection ran Aug 26 – Oct 27, 2020, and the Form 483 is dated October 27, 2020.
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.