Apothecary Pharma LLC
Form 483 issued May 15, 2025 · Cary, North Carolina
- Inspection
- May 12 – May 15, 2025
- Investigators
- Justine C. Tomasso· Sarah M. Gauna· Xiaohui Shen
- Observations
- 8
- Pages
- 6
- FEI number
- 3032314463
In short: On May 15, 2025, FDA issued a Form 483 with 8 observations to Apothecary Pharma LLC in Cary, North Carolina (FEI 3032314463) after an inspection that ran May 12 – May 15, 2025. The investigators were Justine C. Tomasso, Sarah M. Gauna and Xiaohui Shen. 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 6 of 8 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Protective apparel is not worn as necessaiy to protect…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Justine C. Tomasso
5 documents · 2012–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmApothecary Pharma LLC history
All 2 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 Apothecary Pharma LLC?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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 Apothecary Pharma LLC?
Justine C. Tomasso, Sarah M. Gauna and Xiaohui Shen are named on this Form 483, for the inspection of May 12 – May 15, 2025. Each investigator has a profile showing what they cite most.
When was Apothecary Pharma LLC inspected by FDA?
The inspection ran May 12 – May 15, 2025, and the Form 483 is dated May 15, 2025.
How do I get the full Form 483 for Apothecary Pharma LLC?
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.