Anderson Holdings Inc.
Form 483 issued February 19, 2016 · Nashua, New Hampshire
- Inspection
- Feb 2 – Feb 19, 2016
- Investigators
- Dien N. Nguyen· John P. Mistler· Stacey S. Degarmo
- Observations
- 8
- Pages
- 5
- FEI number
- 3011859261
In short: On February 19, 2016, FDA issued a Form 483 with 8 observations to Anderson Holdings Inc. in Nashua, New Hampshire (FEI 3011859261) after an inspection that ran Feb 2 – Feb 19, 2016. The investigators were Dien N. Nguyen, John P. Mistler and Stacey S. Degarmo. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and facilities & equipment account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Dien N. Nguyen
6 documents · 2016–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Connecticut.
The firmAnderson Holdings Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Anderson Holdings Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Anderson Holdings Inc.?
Dien N. Nguyen, John P. Mistler and Stacey S. Degarmo are named on this Form 483, for the inspection of Feb 2 – Feb 19, 2016. Each investigator has a profile showing what they cite most.
When was Anderson Holdings Inc. inspected by FDA?
The inspection ran Feb 2 – Feb 19, 2016, and the Form 483 is dated February 19, 2016.
How do I get the full Form 483 for Anderson Holdings 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.