Alphapharm Pty Ltd.
Form 483 issued June 28, 2024 · Carole Park, Australia
- Inspection
- Jun 24 – Jun 28, 2024
- Investigator
- Anastasia M. Shields
- Observations
- 2
- Pages
- 3
- FEI number
- 3002806388
In short: On June 28, 2024, FDA issued a Form 483 with 2 observations to Alphapharm Pty Ltd. in Carole Park, QLD (FEI 3002806388) after an inspection that ran Jun 24 – Jun 28, 2024. The investigator was Anastasia M. Shields. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67(b) (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Deviations from written production and process control…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmAlphapharm Pty Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alphapharm Pty Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Alphapharm Pty Ltd.?
Anastasia M. Shields is named on this Form 483, for the inspection of Jun 24 – Jun 28, 2024. Each investigator has a profile showing what they cite most.
When was Alphapharm Pty Ltd. inspected by FDA?
The inspection ran Jun 24 – Jun 28, 2024, and the Form 483 is dated June 28, 2024.
How do I get the full Form 483 for Alphapharm Pty Ltd.?
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