Biomedical Tissue Services, Ltd.
Form 483 issued September 30, 2003 · Fort Lee, New Jersey
- Inspection
- Sep 19 – Sep 30, 2003
- Investigator
- Helen B. Ricalde
- Observations
- 2
- Pages
- 83
- FEI number
- 3003652678
In short: On September 30, 2003, FDA issued a Form 483 with 2 observations to Biomedical Tissue Services, Ltd. in Fort Lee, New Jersey (FEI 3003652678) after an inspection that ran Sep 19 – Sep 30, 2003. The investigator was Helen B. Ricalde. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.200 (equipment).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.200 (1×) · 1271.270 (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 validate and follow written procedures for prevention…
- 02
Records fail to include documentation of destruction or other…
This inspection in context
Helen B. Ricalde
9 documents · 2003–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmBiomedical Tissue Services, Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.200
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biomedical Tissue Services, Ltd.?
FDA listed 2 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.
Who inspected Biomedical Tissue Services, Ltd.?
Helen B. Ricalde is named on this Form 483, for the inspection of Sep 19 – Sep 30, 2003. Each investigator has a profile showing what they cite most.
When was Biomedical Tissue Services, Ltd. inspected by FDA?
The inspection ran Sep 19 – Sep 30, 2003, and the Form 483 is dated September 30, 2003.
How do I get the full Form 483 for Biomedical Tissue Services, Ltd.?
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.