Sharp Sterile Manufacturing, LLC
Form 483 issued January 1, 2006 · Lee, Massachusetts
- Inspection
- Feb 17 – Mar 5, 2026
- Investigators
- Erik W. Koester· Syeda N. Mahazabin
- Observations
- 6
- Pages
- 6
- FEI number
- 3012144557
In short: On January 1, 2006, FDA issued a Form 483 with 6 observations to Sharp Sterile Manufacturing, LLC in Lee, Massachusetts (FEI 3012144557) after an inspection that ran Feb 17 – Mar 5, 2026. The investigators were Erik W. Koester and Syeda N. Mahazabin. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 05
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) 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 211.192
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 quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Sharp Sterile Manufacturing, LLC?
Erik W. Koester and Syeda N. Mahazabin are named on this Form 483, for the inspection of Feb 17 – Mar 5, 2026. Each investigator has a profile showing what they cite most.
When was Sharp Sterile Manufacturing, LLC inspected by FDA?
The inspection ran Feb 17 – Mar 5, 2026, and the Form 483 is dated January 1, 2006.
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.