Sharp Sterile Manufacturing, LLC
Form 483 issued May 23, 2022 · Lee, Massachusetts
- Inspection
- May 9 – May 23, 2022
- Investigator
- Erik W. Koester
- Observations
- 2
- Pages
- 3
- FEI number
- 3012144557
In short: On May 23, 2022, FDA issued a Form 483 with 2 observations to Sharp Sterile Manufacturing, LLC in Lee, Massachusetts (FEI 3012144557) after an inspection that ran May 9 – May 23, 2022. The investigator was Erik W. Koester. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.170 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Sterile Manufacturing, LLC?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Sharp Sterile Manufacturing, LLC?
Erik W. Koester is named on this Form 483, for the inspection of May 9 – May 23, 2022. Each investigator has a profile showing what they cite most.
When was Sharp Sterile Manufacturing, LLC inspected by FDA?
The inspection ran May 9 – May 23, 2022, and the Form 483 is dated May 23, 2022.
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.