American National Red Cross, Penn Jersey Region
Form 483 issued June 4, 2010 · Philadelphia, Pennsylvania
- Inspection
- May 24 – Jun 4, 2010
- Investigators
- John M. Mastalski· Michele M. Falchek
- Observations
- 2
- Pages
- 3
- FEI number
- 2573021
In short: On June 4, 2010, FDA issued a Form 483 with 2 observations to American National Red Cross, Penn Jersey Region in Philadelphia, Pennsylvania (FEI 2573021) after an inspection that ran May 24 – Jun 4, 2010. The investigators were John M. Mastalski and Michele M. Falchek. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.171 (reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.171 (1×) · 606.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to perform a thorough investigation and make a record ofthe conclusions and…
- 02
Written standard operating procedures including all steps to be followed in the collection and processing ofblood…
This inspection in context
John M. Mastalski
15 documents · 2010–2019
Cites 118.10(a)(3)(ii) (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAmerican National Red Cross, Penn Jersey Region history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 606.171
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American National Red Cross, Penn Jersey Region?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.171 (reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services). The opening words of each observation are shown on this page.
Who inspected American National Red Cross, Penn Jersey Region?
John M. Mastalski and Michele M. Falchek are named on this Form 483, for the inspection of May 24 – Jun 4, 2010. Each investigator has a profile showing what they cite most.
When was American National Red Cross, Penn Jersey Region inspected by FDA?
The inspection ran May 24 – Jun 4, 2010, and the Form 483 is dated June 4, 2010.
How do I get the full Form 483 for American National Red Cross, Penn Jersey Region?
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.