MSN PHARMACEUTICALS INC
Form 483 issued June 16, 2021 · Piscataway, New Jersey
- Inspection
- May 3 – Jun 16, 2021
- Observations
- 11
- Pages
- 16
- FEI number
- 3014645733
In short: On June 16, 2021, FDA issued a Form 483 with 11 observations to MSN PHARMACEUTICALS INC in Piscataway, New Jersey (FEI 3014645733) after an inspection that ran May 3 – Jun 16, 2021. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Production and laboratory controls account for 9 of 11 observations.
Most cited: 21 CFR 211.160 (3×) · 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include complete information relating to the production and…
- 02
There is no documentation that supports sampling plans were executed as…
- 03
Hold Time stability studies samples are not pulled for testing as per protocols…
- 04
Representative samples are not taken of each shipment of each lot of components…
This inspection in context
Questions about this 483
What did FDA find at MSN PHARMACEUTICALS INC?
FDA listed 11 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was MSN PHARMACEUTICALS INC inspected by FDA?
The inspection ran May 3 – Jun 16, 2021, and the Form 483 is dated June 16, 2021.
How do I get the full Form 483 for MSN PHARMACEUTICALS INC?
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.