Garonit Pharmaceutical, Inc.
Form 483 issued July 6, 2023 · Fairfield, New Jersey
- Investigator
- Janet A. Rajan
- Observations
- 2
- Pages
- 3
- FEI number
- 3003961853
In short: On July 6, 2023, FDA issued a Form 483 with 2 observations to Garonit Pharmaceutical, Inc. in Fairfield, New Jersey (FEI 3003961853). The investigator was Janet A. Rajan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Repeat Observation) Failure to extend investigations to other batches that may have been associated with a…
- 02
Failure to ensure all deviations are documented and investigated, and that…
This inspection in context
Janet A. Rajan
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmGaronit Pharmaceutical, Inc. 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 Garonit Pharmaceutical, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Garonit Pharmaceutical, Inc.?
Janet A. Rajan is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Garonit Pharmaceutical, Inc. inspected by FDA?
This Form 483 is dated July 6, 2023.
How do I get the full Form 483 for Garonit Pharmaceutical, Inc.?
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.