Caraco Pharmaceutical Laboratories
Form 483 issued December 22, 2008 · Farmington Hills, Michigan
- Inspection
- Dec 11 – Dec 22, 2008
- Investigators
- Adam J. Wilson· Jonathan R. Loving· Patsy J. Domingo
- Observations
- 5
- Pages
- 3
- FEI number
- 3006389940
In short: On December 22, 2008, FDA issued a Form 483 with 5 observations to Caraco Pharmaceutical Laboratories in Farmington Hills, Michigan (FEI 3006389940) after an inspection that ran Dec 11 – Dec 22, 2008. The investigators were Adam J. Wilson, Jonathan R. Loving and Patsy J. Domingo. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.182 (equipment cleaning and use log).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.182 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inspection of the packaging facilities immediately before use is not done to assure that all drug…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Adam J. Wilson
2 documents · 2008
Cites 211.182 (equipment cleaning and use log) more than any other section. Most of their documents are for sites in Michigan.
The firmCaraco Pharmaceutical Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.182
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Caraco Pharmaceutical Laboratories?
FDA listed 5 observations on this Form 483, mostly about quality system, packaging & labeling and production. The most-cited regulation is 21 CFR 211.182 (equipment cleaning and use log). The opening words of each observation are shown on this page.
Who inspected Caraco Pharmaceutical Laboratories?
Adam J. Wilson, Jonathan R. Loving and Patsy J. Domingo are named on this Form 483, for the inspection of Dec 11 – Dec 22, 2008. Each investigator has a profile showing what they cite most.
When was Caraco Pharmaceutical Laboratories inspected by FDA?
The inspection ran Dec 11 – Dec 22, 2008, and the Form 483 is dated December 22, 2008.
How do I get the full Form 483 for Caraco Pharmaceutical Laboratories?
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.