Arrow Pharm (Malta) Ltd
Form 483 issued February 9, 2017 · Birzebbugia,, Malta
- Observations
- 2
- Pages
- 2
- FEI number
- 3005688405
In short: On February 9, 2017, FDA issued a Form 483 with 2 observations to Arrow Pharm (Malta) Ltd in Birzebbugia,, Malta (FEI 3005688405). Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.166 (1×) · 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
The written stability program for drug products does not include test intervals based on statistical criteria…
- 02
The work conducted to validate the manual cleaning activities and to demonstrate the efficiency of cleaning…
This inspection in context
Questions about this 483
What did FDA find at Arrow Pharm (Malta) Ltd?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
When was Arrow Pharm (Malta) Ltd inspected by FDA?
This Form 483 is dated February 9, 2017.
How do I get the full Form 483 for Arrow Pharm (Malta) 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.