Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals
Form 483 issued September 20, 2024 · Bristol, Tennessee
- Inspection
- Sep 16 – Sep 20, 2024
- Investigators
- Rodney L. Tinzie· William V. Millar
- Observations
- 5
- Pages
- 6
- FEI number
- 1000208638
In short: On September 20, 2024, FDA issued a Form 483 with 5 observations to Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals in Bristol, Tennessee (FEI 1000208638) after an inspection that ran Sep 16 – Sep 20, 2024. The investigators were Rodney L. Tinzie and William V. Millar. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 03
Buildings used in the of a drug product are not maintained in a…
- 04
Established laboratory control mechanisms…
This inspection in context
Rodney L. Tinzie
7 documents · 2023–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Texas.
The firmGregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals?
Rodney L. Tinzie and William V. Millar are named on this Form 483, for the inspection of Sep 16 – Sep 20, 2024. Each investigator has a profile showing what they cite most.
When was Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals inspected by FDA?
The inspection ran Sep 16 – Sep 20, 2024, and the Form 483 is dated September 20, 2024.
How do I get the full Form 483 for Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals?
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