Bedford Pharmacy Inc.
Form 483 issued August 28, 2015 · Bedford, New Hampshire
- Inspection
- Aug 28, 2015
- Investigators
- John P. Mistler· Stacey S. Degarmo
- Observations
- 6
- Pages
- 5
- FEI number
- 3003687986
In short: On August 28, 2015, FDA issued a Form 483 with 6 observations to Bedford Pharmacy Inc. in Bedford, New Hampshire (FEI 3003687986) after an inspection that ran Aug 28, 2015. The investigators were John P. Mistler and Stacey S. Degarmo. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
Each batch of dmg product required to be free of objectionable nucroorganisms is not tested…
This inspection in context
John P. Mistler
15 documents · 2015–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBedford Pharmacy Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bedford Pharmacy Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and packaging & labeling. 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 Bedford Pharmacy Inc.?
John P. Mistler and Stacey S. Degarmo are named on this Form 483, for the inspection of Aug 28, 2015. Each investigator has a profile showing what they cite most.
When was Bedford Pharmacy Inc. inspected by FDA?
The inspection ran Aug 28, 2015, and the Form 483 is dated August 28, 2015.
How do I get the full Form 483 for Bedford Pharmacy 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.