Astellas Pharma Technologies
Form 483 issued June 24, 2015 · Norman, Oklahoma
- Inspection
- Jun 17 – Jun 24, 2015
- Investigators
- Cassandra L. Abellard· Walden H. Lee· William Leonard
- Observations
- 7
- Pages
- 6
- FEI number
- 3004998655
In short: On June 24, 2015, FDA issued a Form 483 with 7 observations to Astellas Pharma Technologies in Norman, Oklahoma (FEI 3004998655) after an inspection that ran Jun 17 – Jun 24, 2015. The investigators were Cassandra L. Abellard, Walden H. Lee and William Leonard. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Cassandra L. Abellard
6 documents · 2015–2023
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAstellas Pharma Technologies history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Astellas Pharma Technologies?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Astellas Pharma Technologies?
Cassandra L. Abellard, Walden H. Lee and William Leonard are named on this Form 483, for the inspection of Jun 17 – Jun 24, 2015. Each investigator has a profile showing what they cite most.
When was Astellas Pharma Technologies inspected by FDA?
The inspection ran Jun 17 – Jun 24, 2015, and the Form 483 is dated June 24, 2015.
How do I get the full Form 483 for Astellas Pharma Technologies?
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