DePuy San Antonio
Form 483 issued October 28, 2009 · San Antonio, Texas
- Inspection
- Oct 23 – Oct 28, 2009
- Investigator
- Blondell W. Johnson
- Observations
- 5
- Pages
- 2
- FEI number
- 3005338525
In short: On October 28, 2009, FDA issued a Form 483 with 5 observations to DePuy San Antonio in San Antonio, Texas (FEI 3005338525) after an inspection that ran Oct 23 – Oct 28, 2009. The investigator was Blondell W. Johnson. Most observations concern hCT/P.
At a glance
5 of 5 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observation- 01
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps manufactured…
- 02
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture…
- 03
Storage temperatures ofHCT/Ps were…
- 04
Procedures for determining if HCT/Ps that were returned to the establislunent are su itable to be…
This inspection in context
Blondell W. Johnson
1 document · 2009
Cites 1271.160(a) (establishment and maintenance of a quality program) more than any other section. Most of their documents are for sites in Texas.
The firmDePuy San Antonio history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DePuy San Antonio?
FDA listed 5 observations on this Form 483, mostly about hCT/P. The opening words of each observation are shown on this page.
Who inspected DePuy San Antonio?
Blondell W. Johnson is named on this Form 483, for the inspection of Oct 23 – Oct 28, 2009. Each investigator has a profile showing what they cite most.
When was DePuy San Antonio inspected by FDA?
The inspection ran Oct 23 – Oct 28, 2009, and the Form 483 is dated October 28, 2009.
How do I get the full Form 483 for DePuy San Antonio?
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.