Garonit Pharmaceutical, Inc.
FDA inspection history in Fairfield, New Jersey, 2020 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Fairfield, New Jersey.
- 2023One Form 483, at Fairfield, New Jersey.
- 2023The longest 483 on file: 2 observations over 3 pages at Fairfield, New Jersey.
Cited most
Across all Garonit Pharmaceutical observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.194Laboratory records1
The complete Garonit Pharmaceutical 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
Fairfield, New Jersey
Two Form 483s · 2020 to 2023 · 2 observations
Latest: Form 483, Jul 6, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-06 | 483 Form 483 | Fairfield, New Jersey | 2 | $99 |
| 2020-01-14 | 483 Form 483 | Fairfield, New Jersey | — | $99 |
Investigators on these documents
FEI number 3003961853 · most recent document Jul 6, 2023
About Garonit Pharmaceutical, Inc.
How many FDA Form 483s has Garonit Pharmaceutical, Inc. received?
FDA Intel has 2 Form 483s on file for Garonit Pharmaceutical, Inc.; the most recent is dated Jul 6, 2023.
When was Garonit Pharmaceutical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Garonit Pharmaceutical, Inc. is a Form 483 dated Jul 6, 2023, for the site in Fairfield, New Jersey.
What did FDA cite at Garonit Pharmaceutical, Inc.?
The regulations cited most in the observations on file for Garonit Pharmaceutical, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.