Unither Manufacturing LLC
FDA inspection history in Rochester, New York, 2019 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, at Rochester, New York.
- 2021The longest 483 on file: 5 observations over 5 pages at Rochester, New York.
Cited most
Across all Unither Manufacturing observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.188(b)(2)Batch production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42Design and construction features1
The complete Unither Manufacturing file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Rochester, New York
Two Form 483s · 2019 to 2021 · 8 observations
Latest: Form 483, Oct 15, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-10-15 | 483 Form 483 | Rochester, New York | 5 | $99 |
| 2019-05-22 | 483 Form 483 | Rochester, New York | 3 | $99 |
Investigators on these documents
Johnna L. Bleem (1)Niketa Patel (1)Syeda N. Mahazabin (1)William Leonard (1)
FEI number 1314625 · most recent document Oct 15, 2021
About Unither Manufacturing LLC
How many FDA Form 483s has Unither Manufacturing LLC received?
FDA Intel has 2 Form 483s on file for Unither Manufacturing LLC; the most recent is dated Oct 15, 2021.
When was Unither Manufacturing LLC last inspected by FDA?
The most recent FDA inspection document on file for Unither Manufacturing LLC is a Form 483 dated Oct 15, 2021, for the site in Rochester, New York.
What did FDA cite at Unither Manufacturing LLC?
The regulations cited most in the observations on file for Unither Manufacturing LLC are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.188(b)(2) (Batch production and control records), 1 time.