Vet Pharma Friesoythe GmbH
Form 483 issued March 24, 2023 · Friesoythe, Germany
- Inspection
- Mar 16 – Mar 24, 2023
- Investigator
- Justin A. Boyd
- Observations
- 9
- Pages
- 14
- FEI number
- 3002808866
In short: On March 24, 2023, FDA issued a Form 483 with 9 observations to Vet Pharma Friesoythe GmbH in Friesoythe, Germany (FEI 3002808866) after an inspection that ran Mar 16 – Mar 24, 2023. The investigator was Justin A. Boyd. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products…
- 02
Observation 2: scanned text, readable in the full document.
- 03
(b) (4) processing areas are deficient regarding the system for cleaning and disinfecting the room and…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmVet Pharma Friesoythe GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vet Pharma Friesoythe GmbH?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Vet Pharma Friesoythe GmbH?
Justin A. Boyd is named on this Form 483, for the inspection of Mar 16 – Mar 24, 2023. Each investigator has a profile showing what they cite most.
When was Vet Pharma Friesoythe GmbH inspected by FDA?
The inspection ran Mar 16 – Mar 24, 2023, and the Form 483 is dated March 24, 2023.
How do I get the full Form 483 for Vet Pharma Friesoythe GmbH?
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