FDA Intel

Pine Pharmaceuticals, LLC

Form 483 issued September 30, 2024 · Tonawanda, New York

Inspection
Aug 5 – Sep 30, 2024
Investigators
Jazmine N. Brown· Lauren H. Augustyniak· Simone E. Pitts
Observations
9
Pages
13
FEI number
3010943533

In short: On September 30, 2024, FDA issued a Form 483 with 9 observations to Pine Pharmaceuticals, LLC in Tonawanda, New York (FEI 3010943533) after an inspection that ran Aug 5 – Sep 30, 2024. The investigators were Jazmine N. Brown, Lauren H. Augustyniak, Simone E. Pitts and Ucheabuchi C. Chudi-Nwankwor. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 8 of 9 observations.

Facilities & equipment4
Production4
Quality system1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.42(c)(10)(iii)

    Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…

  2. 02
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  3. 03
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be…

  4. 04
    21 CFR 211.42(c)(10)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…

5 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Jazmine N. Brown

14 documents · 2022–2025

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.

The firm

Pine Pharmaceuticals, LLC history

All 8 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42(c)(10)(iii)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Pine Pharmaceuticals, LLC?

FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production 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 Pine Pharmaceuticals, LLC?

Jazmine N. Brown, Lauren H. Augustyniak, Simone E. Pitts and Ucheabuchi C. Chudi-Nwankwor are named on this Form 483, for the inspection of Aug 5 – Sep 30, 2024. Each investigator has a profile showing what they cite most.

When was Pine Pharmaceuticals, LLC inspected by FDA?

The inspection ran Aug 5 – Sep 30, 2024, and the Form 483 is dated September 30, 2024.

How do I get the full Form 483 for Pine Pharmaceuticals, LLC?

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