Caraco Pharmaceutical Laboratories, Ltd.
Form 483 issued January 11, 2013 · Detroit, Michigan
- Inspection
- Jan 7 – Jan 11, 2013
- Investigators
- Andrew J. Idzior· Rebecca E. Dombrowski· Robert M. Barbosa
- Observations
- 2
- Pages
- 2
- FEI number
- 1833173
In short: On January 11, 2013, FDA issued a Form 483 with 2 observations to Caraco Pharmaceutical Laboratories, Ltd. in Detroit, Michigan (FEI 1833173) after an inspection that ran Jan 7 – Jan 11, 2013. The investigators were Andrew J. Idzior, Rebecca E. Dombrowski and Robert M. Barbosa. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.142 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Dntg products are nor stored under appropriate conditions of temperature and humidity so that their identity…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Andrew J. Idzior
6 documents · 2013–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmCaraco Pharmaceutical Laboratories, Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.142
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Caraco Pharmaceutical Laboratories, Ltd.?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected Caraco Pharmaceutical Laboratories, Ltd.?
Andrew J. Idzior, Rebecca E. Dombrowski and Robert M. Barbosa are named on this Form 483, for the inspection of Jan 7 – Jan 11, 2013. Each investigator has a profile showing what they cite most.
When was Caraco Pharmaceutical Laboratories, Ltd. inspected by FDA?
The inspection ran Jan 7 – Jan 11, 2013, and the Form 483 is dated January 11, 2013.
How do I get the full Form 483 for Caraco Pharmaceutical Laboratories, 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.