Aventied’harma Ltd
Form 483 issued January 15, 2016 · Holmes Chapel, United Kingdom
- Inspection
- Jan 11 – Jan 15, 2016
- Observations
- 1
- Pages
- 1
- FEI number
- 3001621739
In short: On January 15, 2016, FDA issued a Form 483 with 1 observation to Aventied’harma Ltd in Holmes Chapel, United Kingdom (FEI 3001621739) after an inspection that ran Jan 11 – Jan 15, 2016. Most observations concern production; the most-cited regulation is 21 CFR 211.186 (master production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.186 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Aventied’harma Ltd?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.186 (master production and control records). The opening words of each observation are shown on this page.
When was Aventied’harma Ltd inspected by FDA?
The inspection ran Jan 11 – Jan 15, 2016, and the Form 483 is dated January 15, 2016.
How do I get the full Form 483 for Aventied’harma Ltd?
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.