Care-Tech Labs Inc.
Form 483 issued May 22, 2008 · Saint Louis, Missouri
- Inspection
- May 1, 2008
- Investigators
- Ingrid Y. Johnson· Warren J. Lopicka
- Observations
- 23
- Pages
- 14
- FEI number
- 1940465
In short: On May 22, 2008, FDA issued a Form 483 with 23 observations to Care-Tech Labs Inc. in Saint Louis, Missouri (FEI 1940465) after an inspection that ran May 1, 2008. The investigators were Ingrid Y. Johnson and Warren J. Lopicka. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed that describe the in-process controls, tests, and examinations to…
- 02
Deviations from written production and process control…
- 03
Investigations of an unexplained discrepancy and a failure ofa batch or any of its components to…
- 04
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
This inspection in context
Ingrid Y. Johnson
1 document · 2008
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Missouri.
The firmCare-Tech Labs Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Care-Tech Labs Inc.?
FDA listed 23 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Care-Tech Labs Inc.?
Ingrid Y. Johnson and Warren J. Lopicka are named on this Form 483, for the inspection of May 1, 2008. Each investigator has a profile showing what they cite most.
When was Care-Tech Labs Inc. inspected by FDA?
The inspection ran May 1, 2008, and the Form 483 is dated May 22, 2008.
How do I get the full Form 483 for Care-Tech Labs Inc.?
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.