EMS ACQUISITION CORP.
Form 483 issued July 22, 2022 · Hatfield, Pennsylvania
- Observations
- 1
- Pages
- 3
- FEI number
- 2510480
In short: On July 22, 2022, FDA issued a Form 483 with 1 observation to EMS ACQUISITION CORP. in Hatfield, Pennsylvania (FEI 2510480). Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Questions about this 483
What did FDA find at EMS ACQUISITION CORP.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was EMS ACQUISITION CORP. inspected by FDA?
This Form 483 is dated July 22, 2022.
How do I get the full Form 483 for EMS ACQUISITION CORP.?
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.