Pharmacy Resources Incorporated
Form 483 issued January 29, 2019 · Denver, Colorado
- Inspection
- Jan 9 – Jan 29, 2019
- Investigator
- Linda F. Murphy
- Observations
- 7
- Pages
- 6
- FEI number
- 3002946837
In short: On January 29, 2019, FDA issued a Form 483 with 7 observations to Pharmacy Resources Incorporated in Denver, Colorado (FEI 3002946837) after an inspection that ran Jan 9 – Jan 29, 2019. The investigator was Linda F. Murphy. 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 5 of 7 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Products Protective apparel is not worn as necessruy to protect…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmPharmacy Resources Incorporated history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmacy Resources Incorporated?
FDA listed 7 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 Pharmacy Resources Incorporated?
Linda F. Murphy is named on this Form 483, for the inspection of Jan 9 – Jan 29, 2019. Each investigator has a profile showing what they cite most.
When was Pharmacy Resources Incorporated inspected by FDA?
The inspection ran Jan 9 – Jan 29, 2019, and the Form 483 is dated January 29, 2019.
How do I get the full Form 483 for Pharmacy Resources Incorporated?
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.