Pharmaceutical Specialties, Inc.
Form 483 issued May 3, 2019 · Rochester, Minnesota
- Inspection
- Apr 25 – May 3, 2019
- Investigator
- Scott A. Golladay
- Observations
- 3
- Pages
- 3
- FEI number
- 2150117
In short: On May 3, 2019, FDA issued a Form 483 with 3 observations to Pharmaceutical Specialties, Inc. in Rochester, Minnesota (FEI 2150117) after an inspection that ran Apr 25 – May 3, 2019. The investigator was Scott A. Golladay. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Scott A. Golladay
7 documents · 2018–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Minnesota.
The firmPharmaceutical Specialties, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutical Specialties, Inc.?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pharmaceutical Specialties, Inc.?
Scott A. Golladay is named on this Form 483, for the inspection of Apr 25 – May 3, 2019. Each investigator has a profile showing what they cite most.
When was Pharmaceutical Specialties, Inc. inspected by FDA?
The inspection ran Apr 25 – May 3, 2019, and the Form 483 is dated May 3, 2019.
How do I get the full Form 483 for Pharmaceutical Specialties, 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.