Bedford Pharmacy Inc.
Form 483 issued August 17, 2017 · Bedford, New Hampshire
- Inspection
- Aug 2 – Aug 17, 2017
- Investigator
- John P. Mistler
- Observations
- 6
- Pages
- 5
- FEI number
- 3003687986
In short: On August 17, 2017, FDA issued a Form 483 with 6 observations to Bedford Pharmacy Inc. in Bedford, New Hampshire (FEI 3003687986) after an inspection that ran Aug 2 – Aug 17, 2017. The investigator was John P. Mistler. Most observations concern laboratory controls and materials.
At a glance
Laboratory controls and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Each component is not tested for conformity with all appropriate written specifications for…
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 211.165
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 laboratory controls, materials and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Bedford Pharmacy Inc.?
John P. Mistler is named on this Form 483, for the inspection of Aug 2 – Aug 17, 2017. Each investigator has a profile showing what they cite most.
When was Bedford Pharmacy Inc. inspected by FDA?
The inspection ran Aug 2 – Aug 17, 2017, and the Form 483 is dated August 17, 2017.
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.