Unither Manufacturing LLC
Form 483 issued October 15, 2021 · Rochester, New York
- Inspection
- Oct 4 – Oct 15, 2021
- Investigators
- Syeda N. Mahazabin· William Leonard
- Observations
- 5
- Pages
- 5
- FEI number
- 1314625
In short: On October 15, 2021, FDA issued a Form 483 with 5 observations to Unither Manufacturing LLC in Rochester, New York (FEI 1314625) after an inspection that ran Oct 4 – Oct 15, 2021. The investigators were Syeda N. Mahazabin and William Leonard. 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 observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent contamination that would…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Written procedures are lacking which describe in sufficient detail…
This inspection in context
Syeda N. Mahazabin
19 documents · 2006–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmUnither Manufacturing LLC history
All 2 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 Unither Manufacturing LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Unither Manufacturing LLC?
Syeda N. Mahazabin and William Leonard 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 Unither 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 Unither 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.