Prescription Labs, Inc. dba Greenpark Compounding Pharmacy
Form 483 issued August 12, 2021 · Houston, Texas
- Inspection
- Jul 2 – Aug 12, 2021
- Investigator
- Camerson E. Moore
- Observations
- 10
- Pages
- 14
- FEI number
- 3009712882
In short: On August 12, 2021, FDA issued a Form 483 with 10 observations to Prescription Labs, Inc. dba Greenpark Compounding Pharmacy in Houston, Texas (FEI 3009712882) after an inspection that ran Jul 2 – Aug 12, 2021. The investigator was Camerson E. Moore. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 10 observations.
Most cited: 21 CFR 211.113 (4×) · 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel engaged in aseptic processing were…
- 02
Your firm released drug product in which the strength differs from, or its purity or quality…
- 03
used to sterilize…
- 04
No assurance that sterile drug products were processed and stored under…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmPrescription Labs, Inc. dba Greenpark Compounding Pharmacy 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Prescription Labs, Inc. dba Greenpark Compounding Pharmacy?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Prescription Labs, Inc. dba Greenpark Compounding Pharmacy?
Camerson E. Moore is named on this Form 483, for the inspection of Jul 2 – Aug 12, 2021. Each investigator has a profile showing what they cite most.
When was Prescription Labs, Inc. dba Greenpark Compounding Pharmacy inspected by FDA?
The inspection ran Jul 2 – Aug 12, 2021, and the Form 483 is dated August 12, 2021.
How do I get the full Form 483 for Prescription Labs, Inc. dba Greenpark Compounding Pharmacy?
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.