Biomet Texas
Form 483 issued March 31, 2010 · Da ll a s, Texas
- Inspection
- Mar 29 – Mar 31, 2010
- Investigators
- Darla J. Christopher· Tracy J. Washington
- Observations
- 1
- Pages
- 1
- FEI number
- 3005833534
In short: On March 31, 2010, FDA issued a Form 483 with 1 observation to Biomet Texas in Da ll a s, Texas (FEI 3005833534) after an inspection that ran Mar 29 – Mar 31, 2010. The investigators were Darla J. Christopher and Tracy J. Washington. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 600.10 (personnel).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 600.10(b) (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 600.10(b)
Failure to assure that personnel have a thorough understanding of the…
This inspection in context
Darla J. Christopher
10 documents · 2010–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmBiomet Texas history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Biomet Texas?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 600.10 (personnel). The opening words of each observation are shown on this page.
Who inspected Biomet Texas?
Darla J. Christopher and Tracy J. Washington are named on this Form 483, for the inspection of Mar 29 – Mar 31, 2010. Each investigator has a profile showing what they cite most.
When was Biomet Texas inspected by FDA?
The inspection ran Mar 29 – Mar 31, 2010, and the Form 483 is dated March 31, 2010.
How do I get the full Form 483 for Biomet Texas?
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.