Alkermes, Inc.
Form 483 issued October 19, 2023 · Wilmington, Ohio
- Inspection
- Sep 25 – Oct 19, 2023
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 7
- Pages
- 5
- FEI number
- 1000142940
In short: On October 19, 2023, FDA issued a Form 483 with 7 observations to Alkermes, Inc. in Wilmington, Ohio (FEI 1000142940) after an inspection that ran Sep 25 – Oct 19, 2023. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.68(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Employees are not given training in the particular operations they perform as…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmAlkermes, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alkermes, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Alkermes, Inc.?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Sep 25 – Oct 19, 2023. Each investigator has a profile showing what they cite most.
When was Alkermes, Inc. inspected by FDA?
The inspection ran Sep 25 – Oct 19, 2023, and the Form 483 is dated October 19, 2023.
How do I get the full Form 483 for Alkermes, 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.