Ultratab Laboratories, Inc.
FDA inspection history across 2 sites, 2019 to 2022
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2020: one Form 483; 2021: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–22Three Form 483s and one warning letter, at Highland, New York and New Paltz, New York.
- 2020The longest 483 on file: 7 observations over 8 pages at Highland, New York.
Cited most
Across all Ultratab Laboratories observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 111.205(b)(1)What is the requirement to establish a master manufacturing record?1
- 21 CFR 211.165(e)Testing and release for distribution1
The complete Ultratab Laboratories file.
All 4 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
Highland, New York
Three Form 483s · 2019 to 2021 · 11 observations
Latest: Form 483, Sep 14, 2021 →New Paltz, New York
One warning letter · 2022
Latest: Warning letter, Mar 14, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-14 | Warning letter Warning letter | New Paltz, New York | — | $99 |
| 2021-09-14 | 483 Form 483 | Highland, New York | 3 | $99 |
| 2020-01-31 | 483 Form 483 | Highland, New York | 7 | $99 |
| 2019-02-01 | 483 Form 483 | Highland, New York | 1 | $99 |
Investigators on these documents
FEI number 3003068822 · most recent document Mar 14, 2022
About Ultratab Laboratories, Inc.
How many FDA Form 483s has Ultratab Laboratories, Inc. received?
FDA Intel has 3 Form 483s on file for Ultratab Laboratories, Inc.; the most recent is dated Sep 14, 2021.
When was Ultratab Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Ultratab Laboratories, Inc. is a Form 483 dated Sep 14, 2021, for the site in Highland, New York.
What did FDA cite at Ultratab Laboratories, Inc.?
The regulations cited most in the observations on file for Ultratab Laboratories, Inc. are 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 2 times.
Has Ultratab Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ultratab Laboratories, Inc.; the most recent is dated Mar 14, 2022.