RemedyRepack Inc
Form 483 issued November 23, 2015 · Indiana, Pennsylvania
- Inspection
- Oct 28 – Nov 23, 2015
- Investigator
- Dennis R. Hock
- Observations
- 10
- Pages
- 7
- FEI number
- 3005841768
In short: On November 23, 2015, FDA issued a Form 483 with 10 observations to RemedyRepack Inc in Indiana, Pennsylvania (FEI 3005841768) after an inspection that ran Oct 28 – Nov 23, 2015. The investigator was Dennis R. Hock. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to assure that correct labels and labeling are used for drug…
- 02
Procedures describing in sufficient detail the controls employed for the issuance of…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Routine calibration and inspection and checking of electronic equipment is not performed according to a written…
This inspection in context
Dennis R. Hock
10 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmRemedyRepack Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RemedyRepack Inc?
FDA listed 10 observations on this Form 483, mostly about quality system, packaging & labeling and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected RemedyRepack Inc?
Dennis R. Hock is named on this Form 483, for the inspection of Oct 28 – Nov 23, 2015. Each investigator has a profile showing what they cite most.
When was RemedyRepack Inc inspected by FDA?
The inspection ran Oct 28 – Nov 23, 2015, and the Form 483 is dated November 23, 2015.
How do I get the full Form 483 for RemedyRepack 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.