Valdepharm
Form 483 issued April 27, 2015 · VAL DE REUIL CEDEX, France
- Observations
- 1
- Pages
- 1
- FEI number
- 3000538143
In short: On April 27, 2015, FDA issued a Form 483 with 1 observation to Valdepharm in VAL DE REUIL CEDEX, NORMANDIE (FEI 3000538143). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters…
This inspection in context
Questions about this 483
What did FDA find at Valdepharm?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Valdepharm inspected by FDA?
This Form 483 is dated April 27, 2015.
How do I get the full Form 483 for Valdepharm?
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.