Intergel Pharmaceutical Inc
Form 483 issued November 20, 2018 · Irvington, New Jersey
- Observations
- 2
- Pages
- 1
- FEI number
- 1000526797
In short: On November 20, 2018, FDA issued a Form 483 with 2 observations to Intergel Pharmaceutical Inc in Irvington, New Jersey (FEI 1000526797). Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.180 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for evaluation done at least annually and including provisions for review…
- 02
Routine calibration of mechanical equipment is not performed according to a written program to assure…
This inspection in context
Questions about this 483
What did FDA find at Intergel Pharmaceutical Inc?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
When was Intergel Pharmaceutical Inc inspected by FDA?
This Form 483 is dated November 20, 2018.
How do I get the full Form 483 for Intergel 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.