Northern New England Compounding Pharmacy, LLC
Form 483 issued September 30, 2014 · Littleton, New Hampshire
- Inspection
- Sep 17 – Sep 30, 2014
- Investigator
- Sidney S. Degarmo
- Observations
- 5
- Pages
- 3
- FEI number
- 3005636558
In short: On September 30, 2014, FDA issued a Form 483 with 5 observations to Northern New England Compounding Pharmacy, LLC in Littleton, New Hampshire (FEI 3005636558) after an inspection that ran Sep 17 – Sep 30, 2014. The investigator was Sidney S. Degarmo. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 4 of 5 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
Protective apparel is not worn as necessary to protect…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 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 do not include…
This inspection in context
Sidney S. Degarmo
1 document · 2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Hampshire.
The firmNorthern New England Compounding Pharmacy, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Northern New England Compounding Pharmacy, LLC?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 Northern New England Compounding Pharmacy, LLC?
Sidney S. Degarmo is named on this Form 483, for the inspection of Sep 17 – Sep 30, 2014. Each investigator has a profile showing what they cite most.
When was Northern New England Compounding Pharmacy, LLC inspected by FDA?
The inspection ran Sep 17 – Sep 30, 2014, and the Form 483 is dated September 30, 2014.
How do I get the full Form 483 for Northern New England Compounding Pharmacy, LLC?
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.