MERCK SERONO SA
Form 483 issued July 8, 2022 · Aubonne, Switzerland
- Observations
- 8
- Pages
- 6
- FEI number
- 3002807447
In short: On July 8, 2022, FDA issued a Form 483 with 8 observations to MERCK SERONO SA in Aubonne, Vaud (FEI 3002807447). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 6 of 8 observations.
Most cited: 21 CFR 211.42 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
There is a lack of assurance that yor i rocedures, used for product-contact process equipment used…
This inspection in context
Questions about this 483
What did FDA find at MERCK SERONO SA?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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 MERCK SERONO SA inspected by FDA?
This Form 483 is dated July 8, 2022.
How do I get the full Form 483 for MERCK SERONO SA?
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.