Diamond Drugs, Inc.
Form 483 issued July 21, 2017 · Indiana, Pennsylvania
- Inspection
- Jul 18 – Jul 21, 2017
- Investigator
- Nancy F. Scheraga
- Observations
- 2
- Pages
- 1
- FEI number
- 3013075945
In short: On July 21, 2017, FDA issued a Form 483 with 2 observations to Diamond Drugs, Inc. in Indiana, Pennsylvania (FEI 3013075945) after an inspection that ran Jul 18 – Jul 21, 2017. The investigator was Nancy F. Scheraga. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 laminar air flow hood was not…
- 02
Disinfecting agents used in the ISO 5 laminar air flow…
This inspection in context
Nancy F. Scheraga
9 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmDiamond Drugs, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diamond Drugs, Inc.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Diamond Drugs, Inc.?
Nancy F. Scheraga is named on this Form 483, for the inspection of Jul 18 – Jul 21, 2017. Each investigator has a profile showing what they cite most.
When was Diamond Drugs, Inc. inspected by FDA?
The inspection ran Jul 18 – Jul 21, 2017, and the Form 483 is dated July 21, 2017.
How do I get the full Form 483 for Diamond Drugs, 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.