Appco Pharma LLC
Form 483 issued July 30, 2021 · Piscataway, New Jersey
- Inspection
- Jul 20 – Jul 30, 2021
- Observations
- 1
- Pages
- 2
- FEI number
- 3010014758
In short: On July 30, 2021, FDA issued a Form 483 with 1 observation to Appco Pharma LLC in Piscataway, New Jersey (FEI 3010014758) after an inspection that ran Jul 20 – Jul 30, 2021. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
This inspection in context
Questions about this 483
What did FDA find at Appco Pharma LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Appco Pharma LLC inspected by FDA?
The inspection ran Jul 20 – Jul 30, 2021, and the Form 483 is dated July 30, 2021.
How do I get the full Form 483 for Appco Pharma LLC?
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.