WES Pharma Inc.
Form 483 issued November 21, 2023 · WESTMINSTER, Maryland
- Inspection
- Nov 17 – Nov 21, 2023
- Investigators
- Johnny D. Nwankwo· Olumide A. Akinyemi· Pushpa S. Jayasekara
- Observations
- 2
- Pages
- 4
- FEI number
- 3010062344
In short: On November 21, 2023, FDA issued a Form 483 with 2 observations to WES Pharma Inc. in WESTMINSTER, Maryland (FEI 3010062344) after an inspection that ran Nov 17 – Nov 21, 2023. The investigators were Johnny D. Nwankwo, Olumide A. Akinyemi, Pushpa S. Jayasekara and Yaharn Su. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.63 (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Johnny D. Nwankwo
2 documents · 2023–2024
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Maryland.
The firmWES Pharma Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WES Pharma Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected WES Pharma Inc.?
Johnny D. Nwankwo, Olumide A. Akinyemi, Pushpa S. Jayasekara and Yaharn Su are named on this Form 483, for the inspection of Nov 17 – Nov 21, 2023. Each investigator has a profile showing what they cite most.
When was WES Pharma Inc. inspected by FDA?
The inspection ran Nov 17 – Nov 21, 2023, and the Form 483 is dated November 21, 2023.
How do I get the full Form 483 for WES Pharma 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.