Unither Manufacturing LLC
Form 483 issued May 22, 2019 · Rochester, New York
- Inspection
- May 13 – May 22, 2019
- Investigators
- Johnna L. Bleem· Niketa Patel
- Observations
- 3
- Pages
- 5
- FEI number
- 1314625
In short: On May 22, 2019, FDA issued a Form 483 with 3 observations to Unither Manufacturing LLC in Rochester, New York (FEI 1314625) after an inspection that ran May 13 – May 22, 2019. The investigators were Johnna L. Bleem and Niketa Patel. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Batch production and control records do not include the identity of individual major equipment used for…
- 03
Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Johnna L. Bleem
6 documents · 2019–2021
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 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Unither Manufacturing LLC?
Johnna L. Bleem and Niketa Patel are named on this Form 483, for the inspection of May 13 – May 22, 2019. Each investigator has a profile showing what they cite most.
When was Unither Manufacturing LLC inspected by FDA?
The inspection ran May 13 – May 22, 2019, and the Form 483 is dated May 22, 2019.
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.