US Specialty Formulations LLC

Form 483 issued March 26, 2025 · Allentown, Pennsylvania

Inspection: Mar 19 – Mar 26, 2025
Investigators: Christina K. Theodorou· Lu Chen· Nabihah Amatullah
Observations: 5
Pages: 25
FEI number: 3010680515

In short: On March 26, 2025, FDA issued a Form 483 with 5 observations to US Specialty Formulations LLC in Allentown, Pennsylvania (FEI 3010680515) after an inspection that ran Mar 19 – Mar 26, 2025. The investigators were Christina K. Theodorou, Lu Chen and Nabihah Amatullah. Most observations concern production and laboratory controls.

At a glance

Observations span 4 systems, led by production.

Production1

Laboratory controls1

Facilities & equipment1

Materials1

Other1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
02
21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
03
21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
04
21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for…

1 more observation

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

Get the full 483

This inspection in context

The investigator

Christina K. Theodorou

19 documents · 2016–2026

Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.

The firm

US Specialty Formulations LLC history

All 10 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.100(a)

See how FDA wrote the same problem up elsewhere.

Original PDF$99

✓ All 25 pages, as issued to the firm
✓ Searchable text
✓ Download right after checkout, yours to keep

I agree to the Terms of Service, the licence (internal use by my organization only, no sharing or resale) and the Refund Policy, and I ask for immediate access to the download, so I lose any right to cancel once it's available.

Get it free · first document

Secure checkout · receipt for expenses

Already bought it? Find an order

Licensed for use within your organization. No sharing or resale.

Complete the picture

483
Form 483 from this inspectionMar 26, 2025$99

US Specialty Formulations LLC site file

All 10 documents for this site in one go: $743 instead of ~~$990~~, 25% off.

See the site history

Questions about this 483

What did FDA find at US Specialty Formulations LLC?

FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.

Who inspected US Specialty Formulations LLC?

Christina K. Theodorou, Lu Chen and Nabihah Amatullah are named on this Form 483, for the inspection of Mar 19 – Mar 26, 2025. Each investigator has a profile showing what they cite most.

When was US Specialty Formulations LLC inspected by FDA?

The inspection ran Mar 19 – Mar 26, 2025, and the Form 483 is dated March 26, 2025.

How do I get the full Form 483 for US Specialty Formulations 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.