Guardian Drug Co. Inc
Form 483 issued February 17, 2022 · Dayton, New Jersey
- Inspection
- Jan 26 – Feb 17, 2022
- Investigators
- Edmund F. Mrak· Ko U. Min
- Observations
- 7
- Pages
- 13
- FEI number
- 2245306
In short: On February 17, 2022, FDA issued a Form 483 with 7 observations to Guardian Drug Co. Inc in Dayton, New Jersey (FEI 2245306) after an inspection that ran Jan 26 – Feb 17, 2022. The investigators were Edmund F. Mrak and Ko U. Min. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
The preparation of your master production and control records was not described…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmGuardian Drug Co. Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Guardian Drug Co. Inc?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Guardian Drug Co. Inc?
Edmund F. Mrak and Ko U. Min are named on this Form 483, for the inspection of Jan 26 – Feb 17, 2022. Each investigator has a profile showing what they cite most.
When was Guardian Drug Co. Inc inspected by FDA?
The inspection ran Jan 26 – Feb 17, 2022, and the Form 483 is dated February 17, 2022.
How do I get the full Form 483 for Guardian Drug Co. 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.