RTI Donor Services
Form 483 issued March 23, 2006 · Staten Island, New York
- Inspection
- Mar 21 – Mar 23, 2006
- Observations
- 3
- Pages
- 1
- FEI number
- 3002829089
In short: On March 23, 2006, FDA issued a Form 483 with 3 observations to RTI Donor Services in Staten Island, New York (FEI 3002829089) after an inspection that ran Mar 21 – Mar 23, 2006. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.200 (equipment).
At a glance
3 of 3 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.200 (2×) · 1271.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documentation of equipment maintenance, cleaning, sanitization, and…
- 02
The quality program has not ensured that appropriate procedures related to core…
- 03
Procedures for the cleaning and sanitizing of…
This inspection in context
Questions about this 483
What did FDA find at RTI Donor Services?
FDA listed 3 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.200 (equipment). The opening words of each observation are shown on this page.
When was RTI Donor Services inspected by FDA?
The inspection ran Mar 21 – Mar 23, 2006, and the Form 483 is dated March 23, 2006.
How do I get the full Form 483 for RTI Donor Services?
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.