Caraco Pharmaceutical Laboratories, Ltd.
Form 483 issued May 30, 2020 · Detroit, Michigan
- Inspection
- May 21, 2013 – May 30, 2020
- Investigators
- Aurora-Miha Trifanov· Emily J. Orban
- Observations
- 1
- Pages
- 1
- FEI number
- 1833173
In short: On May 30, 2020, FDA issued a Form 483 with 1 observation to Caraco Pharmaceutical Laboratories, Ltd. in Detroit, Michigan (FEI 1833173) after an inspection that ran May 21, 2013 – May 30, 2020. The investigators were Aurora-Miha Trifanov and Emily J. Orban. Most observations concern materials; the most-cited regulation is 21 CFR 211.94 (drug product containers and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.94 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
This inspection in context
Aurora-Miha Trifanov
2 documents · 2016–2020
Cites 211.111 (time limitations on production) more than any other section. Most of their documents are for sites in Michigan.
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 211.94
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Caraco Pharmaceutical Laboratories, Ltd.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.94 (drug product containers and closures). The opening words of each observation are shown on this page.
Who inspected Caraco Pharmaceutical Laboratories, Ltd.?
Aurora-Miha Trifanov and Emily J. Orban are named on this Form 483, for the inspection of May 21, 2013 – May 30, 2020. Each investigator has a profile showing what they cite most.
When was Caraco Pharmaceutical Laboratories, Ltd. inspected by FDA?
The inspection ran May 21, 2013 – May 30, 2020, and the Form 483 is dated May 30, 2020.
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.