Garonit Pharmaceutical, Inc.
Form 483 issued January 14, 2020 · Fairfield, New Jersey
- Inspection
- Jan 14, 2020
- Observations
- 2
- Pages
- 2
- FEI number
- 3003961853
In short: On January 14, 2020, FDA issued a Form 483 with 2 observations to Garonit Pharmaceutical, Inc. in Fairfield, New Jersey (FEI 3003961853) after an inspection that ran Jan 14, 2020. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to extend investigations to other batches that may have been associated with a…
- 02
Failure to have laboratory control records that include and maintain complete data derived from all laboratory…
This inspection in context
Questions about this 483
What did FDA find at Garonit Pharmaceutical, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Garonit Pharmaceutical, Inc. inspected by FDA?
The inspection ran Jan 14, 2020, and the Form 483 is dated January 14, 2020.
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.