Packpharm Limited
Form 483 issued September 1, 2023 · Norwich, United Kingdom
- Observations
- 3
- Pages
- 3
- FEI number
- 3027274110
In short: On September 1, 2023, FDA issued a Form 483 with 3 observations to Packpharm Limited in Norwich, Norfolk (FEI 3027274110). Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Control procedures are not established which validate the performance of those manufacturing process manufacturing processes that…
- 03
Buildings used in the holding of a drug product are not maintained in a…
This inspection in context
Questions about this 483
What did FDA find at Packpharm Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
When was Packpharm Limited inspected by FDA?
This Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Packpharm Limited?
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.