Pet scri pt Inc
Form 483 issued September 18, 2025 · Paris, Texas
- Inspection
- Sep 8 – Sep 18, 2025
- Investigators
- Katherine M. Breed· Margaret M. Annes
- Observations
- 16
- Pages
- 16
- FEI number
- 3010282564
In short: On September 18, 2025, FDA issued a Form 483 with 16 observations to Pet scri pt Inc in Paris, Texas (FEI 3010282564) after an inspection that ran Sep 8 – Sep 18, 2025. The investigators were Katherine M. Breed and Margaret M. Annes. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Katherine M. Breed
1 document · 2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmPet scri pt Inc history
The site's inspection history, in date order.
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 Pet scri pt Inc?
FDA listed 16 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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 Pet scri pt Inc?
Katherine M. Breed and Margaret M. Annes are named on this Form 483, for the inspection of Sep 8 – Sep 18, 2025. Each investigator has a profile showing what they cite most.
When was Pet scri pt Inc inspected by FDA?
The inspection ran Sep 8 – Sep 18, 2025, and the Form 483 is dated September 18, 2025.
How do I get the full Form 483 for Pet scri pt 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.